Trial Outcomes & Findings for MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012) (NCT NCT00996801)
NCT ID: NCT00996801
Last Updated: 2016-01-22
Results Overview
Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
526 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2016-01-22
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 5 mg
Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 7.5 mg
Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 10 mg
Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 15 mg
Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
Alendronate 70 mg
Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
88
|
87
|
88
|
87
|
|
Overall Study
COMPLETED
|
68
|
72
|
65
|
56
|
0
|
68
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
23
|
31
|
88
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 5 mg
Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 7.5 mg
Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 10 mg
Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 15 mg
Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
Alendronate 70 mg
Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
12
|
17
|
31
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
1
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
3
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
4
|
1
|
2
|
3
|
4
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
0
|
0
|
46
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
9
|
5
|
5
|
9
|
Baseline Characteristics
MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)
Baseline characteristics by cohort
| Measure |
Placebo
n=88 Participants
Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 5 mg
n=88 Participants
Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 7.5 mg
n=88 Participants
Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 10 mg
n=87 Participants
Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 15 mg
n=88 Participants
Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
Alendronate 70 mg
n=87 Participants
Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
Total
n=526 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.8 Years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
66.5 Years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
67.3 Years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
68.2 Years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
68.1 Years
STANDARD_DEVIATION 7.4 • n=31 Participants
|
66.9 Years
STANDARD_DEVIATION 7.5 • n=30 Participants
|
67.5 Years
STANDARD_DEVIATION 7.6 • n=3 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
87 Participants
n=7 Participants
|
88 Participants
n=31 Participants
|
87 Participants
n=30 Participants
|
526 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=82 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=79 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=78 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=79 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)
|
-0.36 percent change
Interval -1.37 to 0.66
|
-0.67 percent change
Interval -1.67 to 0.33
|
-0.52 percent change
Interval -1.56 to 0.52
|
-0.53 percent change
Interval -1.61 to 0.56
|
1.29 percent change
Interval 0.25 to 2.33
|
—
|
PRIMARY outcome
Timeframe: Baseline through Month 12Population: All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (\>2.5 mmol/L). Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a "Tier 1" adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=87 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=88 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=87 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=88 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
n=84 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once
≥10.6 ng/mL
|
3 Participants
|
16 Participants
|
19 Participants
|
27 Participants
|
39 Participants
|
7 Participants
|
|
Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once
≥11.1 ng/mL
|
1 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
19 Participants
|
1 Participants
|
|
Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once
≥12.1 ng/mL
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 12Population: All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.
Albumin-Corrected Calcium = (\[4 - plasma albumin in g/dL\] × 0.8 + serum calcium). ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a "Tier 1" AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=87 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=88 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=87 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=88 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
n=84 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once
≥10.6 ng/mL
|
1 Participants
|
3 Participants
|
7 Participants
|
13 Participants
|
28 Participants
|
2 Participants
|
|
Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once
≥11.1 ng/mL
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once
≥12.1 ng/mL
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 12Population: All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.
Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=87 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=88 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=87 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=88 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
n=84 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Predefined Tier 1 Adverse Events
Osteonecrosis of the jaw
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Predefined Tier 1 Adverse Events
Kidney stones
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Predefined Tier 1 Adverse Events
Bone neoplasms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=82 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=79 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=78 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=79 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD
|
-1.44 percent change
Interval -2.24 to -0.65
|
-2.18 percent change
Interval -2.97 to -1.39
|
-2.16 percent change
Interval -2.98 to -1.33
|
-1.66 percent change
Interval -2.52 to -0.8
|
0.46 percent change
Interval -0.36 to 1.29
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=82 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=79 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=78 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=79 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD
|
-1.26 percent change
Interval -2.15 to -0.36
|
-2.12 percent change
Interval -3.0 to -1.23
|
-1.37 percent change
Interval -2.29 to -0.44
|
-1.84 percent change
Interval -2.8 to -0.88
|
-0.08 percent change
Interval -1.01 to 0.85
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=82 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=79 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=78 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=79 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD
|
-0.30 percent change
Interval -1.35 to 0.76
|
-1.56 percent change
Interval -2.6 to -0.52
|
-1.50 percent change
Interval -2.59 to -0.41
|
-1.52 percent change
Interval -2.66 to -0.38
|
1.68 percent change
Interval 0.59 to 2.76
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=75 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=70 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=74 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=72 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD
|
-0.17 percent change
Interval -0.83 to 0.49
|
-0.54 percent change
Interval -1.18 to 0.1
|
-0.69 percent change
Interval -1.37 to -0.01
|
-1.10 percent change
Interval -1.77 to -0.44
|
0.82 percent change
Interval 0.15 to 1.48
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=72 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=65 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=66 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=69 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD
|
-0.54 percent change
Interval -1.54 to 0.46
|
-1.38 percent change
Interval -2.36 to -0.4
|
-0.92 percent change
Interval -1.95 to 0.12
|
-2.01 percent change
Interval -3.05 to -0.98
|
-0.91 percent change
Interval -1.92 to 0.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm\^3.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=58 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=49 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=49 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=43 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine
|
0.18 percent change
Interval -1.22 to 1.57
|
-0.25 percent change
Interval -1.55 to 1.05
|
0.08 percent change
Interval -1.29 to 1.44
|
0.16 percent change
Interval -1.28 to 1.61
|
1.74 percent change
Interval 0.21 to 3.26
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm\^3.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=57 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=48 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=48 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=45 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip
|
-0.02 percent change
Interval -1.41 to 1.36
|
0.76 percent change
Interval -0.53 to 2.05
|
0.81 percent change
Interval -0.57 to 2.18
|
0.27 percent change
Interval -1.16 to 1.71
|
1.23 percent change
Interval -0.23 to 2.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm\^3.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=58 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=49 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=49 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=43 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine
|
-0.67 percent change
Interval -15.01 to 13.66
|
-3.41 percent change
Interval -16.35 to 9.52
|
14.66 percent change
Interval 0.91 to 28.41
|
-0.34 percent change
Interval -14.49 to 13.82
|
12.80 percent change
Interval -2.31 to 27.92
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcomes analyses were performed.
vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm\^3.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=57 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=48 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=48 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=45 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip
|
0.10 percent change
Interval -0.67 to 0.86
|
-0.49 percent change
Interval -1.19 to 0.22
|
-0.15 percent change
Interval -0.9 to 0.6
|
-0.16 percent change
Interval -0.94 to 0.62
|
0.99 percent change
Interval 0.19 to 1.78
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine. uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=71 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=68 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=73 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=67 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)
|
63.64 percent change
Interval 47.71 to 81.29
|
86.51 percent change
Interval 68.86 to 106.01
|
83.32 percent change
Interval 64.49 to 102.08
|
107.44 percent change
Interval 86.65 to 130.54
|
0.18 percent change
Interval -9.45 to 10.83
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml).
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=73 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=69 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=72 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=71 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)
|
165.80 percent change
Interval 131.23 to 205.54
|
214.09 percent change
Interval 173.92 to 260.15
|
227.07 percent change
Interval 184.11 to 276.53
|
251.08 percent change
Interval 204.31 to 305.04
|
26.78 percent change
Interval 10.58 to 45.36
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=73 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=69 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=73 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=71 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)
|
68.61 percent change
Interval 51.82 to 87.27
|
127.18 percent change
Interval 105.07 to 151.68
|
125.69 percent change
Interval 102.92 to 151.01
|
163.96 percent change
Interval 136.79 to 194.24
|
-5.85 percent change
Interval -14.99 to 4.28
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed.
Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L.
Outcome measures
| Measure |
Placebo
n=69 Participants
Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
|
MK-5442 5 mg
n=72 Participants
Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 7.5mg
n=68 Participants
Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
|
MK-5442 10 mg
n=73 Participants
Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
|
Alendronate 70 mg
n=71 Participants
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
Alendronate 70 mg
Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
|
29.51 percent change
Interval 20.23 to 39.51
|
50.04 percent change
Interval 39.6 to 61.25
|
49.98 percent change
Interval 39.08 to 61.73
|
51.64 percent change
Interval 40.42 to 63.76
|
-3.83 percent change
Interval -10.41 to 3.24
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Analysis of osteocalcin was not conducted when it was determined that the efficacy of MK-5442 was not significantly different than placebo.
Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
MK-5442 5 mg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
MK-5442 7.5 mg
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
MK-5442 10 mg
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
MK-5442 15 mg
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Alendronate 70 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=88 participants at risk
Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 5 mg
n=87 participants at risk
Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 7.5 mg
n=88 participants at risk
Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 10 mg
n=87 participants at risk
Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 15 mg
n=88 participants at risk
Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
Alendronate 70 mg
n=84 participants at risk；n=88 participants at risk
Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary Heart Disease
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tako-Tsubo Cardiomyopathy
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastroenteritis Eosinophilic
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Hernia
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Biliary Fistula
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Acute Appendicitis
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative Pain
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot Osteoarthritis
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.1%
1/88 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer of the Head of the Pancreas
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Latigo Maligna Stage Unspecified
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral Thrombosis
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine with Aura
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Anxiety Aggravated
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thromboembolism
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo
n=88 participants at risk
Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 5 mg
n=87 participants at risk
Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 7.5 mg
n=88 participants at risk
Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 10 mg
n=87 participants at risk
Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
MK-5442 15 mg
n=88 participants at risk
Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
Alendronate 70 mg
n=84 participants at risk；n=88 participants at risk
Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.4%
3/88 • Number of events 3
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
5.7%
5/88 • Number of events 5
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
3.4%
3/87 • Number of events 4
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
2.4%
2/84 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
6.8%
6/88 • Number of events 7
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
5.7%
5/87 • Number of events 5
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
3.4%
3/87 • Number of events 3
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/84
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Urinary Tract Infection
|
5.7%
5/88 • Number of events 9
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
9.2%
8/87 • Number of events 10
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
6.8%
6/88 • Number of events 9
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
6.9%
6/87 • Number of events 8
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
2.3%
2/88 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
6.0%
5/84 • Number of events 6
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
9.1%
8/88 • Number of events 8
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
11.5%
10/87 • Number of events 12
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
26.1%
23/88 • Number of events 23
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/84
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
3/88 • Number of events 3
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
2.3%
2/87 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
9.2%
8/87 • Number of events 8
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
2.3%
2/88 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.2%
1/84 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
1.1%
1/88 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/87
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
6.8%
6/88 • Number of events 6
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
3.4%
3/87 • Number of events 3
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
0.00%
0/88
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.2%
1/84 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
2.3%
2/88 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
8.0%
7/88 • Number of events 7
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
1.1%
1/87 • Number of events 1
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
2.3%
2/88 • Number of events 2
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
3.6%
3/84 • Number of events 3
All Participants as Treated (APaT); all randomized participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60