Trial Outcomes & Findings for Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women (NCT NCT00165698)
NCT ID: NCT00165698
Last Updated: 2014-07-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2014-07-22
Participant Flow
Participant milestones
| Measure |
Menatetrenone
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
112
|
105
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
Reasons for withdrawal
| Measure |
Menatetrenone
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
10
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Not Taken/Lost the medicine
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Baseline characteristics by cohort
| Measure |
Menatetrenone
n=112 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=108 Participants
0.25 μg b.i.d. orally for 12 months
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 6.1 • n=99 Participants
|
64.2 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
64.4 years
STANDARD_DEVIATION 6.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
112 participants
n=99 Participants
|
108 participants
n=107 Participants
|
220 participants
n=206 Participants
|
|
Region of Enrollment
China
|
112 participants
n=99 Participants
|
108 participants
n=107 Participants
|
220 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=105 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
|
1.22 percentage of BMD
Interval -5.35 to 14.14
|
2.17 percentage of BMD
Interval -15.13 to 38.23
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=105 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
|
0.76 percentage of BMD
Interval -18.51 to 19.46
|
0.00 percentage of BMD
Interval -15.84 to 13.8
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=105 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
|
2.66 percentage of BMD
Interval -31.69 to 87.34
|
1.76 percentage of BMD
Interval -38.6 to 74.76
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=103 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months
|
2.39 percentage of BMC
Interval -9.97 to 21.59
|
2.81 percentage of BMC
Interval -16.88 to 19.84
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=103 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months
|
1.58 percentage of BMC
Interval -12.5 to 29.63
|
0.95 percentage of BMC
Interval -21.24 to 15.71
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=104 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months
|
-38.67 percentage of OC
Interval -67.26 to 1.33
|
-25.77 percentage of OC
Interval -65.66 to 57.48
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=104 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months
|
-82.27 percentage of UCOC
Interval -97.27 to 676.6
|
-34.83 percentage of UCOC
Interval -92.07 to 950.0
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=104 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months
|
-70.64 percentage of UCOC/OC
Interval -94.49 to 1185.5
|
-8.47 percentage of UCOC/OC
Interval -85.68 to 610.61
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=105 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
New Fracture and Fall
fracture
|
2 participants
|
4 participants
|
|
New Fracture and Fall
fall
|
13 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Per Protocol Set (PPS)
Outcome measures
| Measure |
Menatetrenone
n=108 Participants
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=105 Participants
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Height (Meter)
Baseline
|
1.54 meters
Standard Deviation 0.05
|
1.55 meters
Standard Deviation 0.05
|
|
Height (Meter)
At 12 months
|
1.54 meters
Standard Deviation 0.06
|
1.55 meters
Standard Deviation 0.05
|
Adverse Events
Menatetrenone
Serious events: 8 serious events
Other events: 81 other events
Deaths: 0 deaths
Alfacalcidol
Serious events: 6 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menatetrenone
n=117 participants at risk
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=118 participants at risk
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin damage
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
1.7%
2/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Tendon damage
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/117
Safety Population
|
0.85%
1/118
Safety Population
|
|
Endocrine disorders
Parathyroid malignant tumor
|
0.00%
0/117
Safety Population
|
0.85%
1/118
Safety Population
|
|
Endocrine disorders
NTT
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Endocrine disorders
Goiter
|
0.85%
1/117
Safety Population
|
0.85%
1/118
Safety Population
|
|
Vascular disorders
Hypertension
|
0.00%
0/117
Safety Population
|
0.85%
1/118
Safety Population
|
|
Cardiac disorders
Chest distress
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
2/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Cardiac disorders
Angina
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Cardiac disorders
Arrhythmia
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
|
Reproductive system and breast disorders
Breast cancer
|
0.00%
0/117
Safety Population
|
0.85%
1/118
Safety Population
|
|
Surgical and medical procedures
Nerve sheath tumor surgery
|
0.00%
0/117
Safety Population
|
0.85%
1/118
Safety Population
|
|
Surgical and medical procedures
Uterus resection
|
0.85%
1/117
Safety Population
|
0.00%
0/118
Safety Population
|
Other adverse events
| Measure |
Menatetrenone
n=117 participants at risk
15 mg t.i.d. orally for 12 months
|
Alfacalcidol
n=118 participants at risk
0.25 μg b.i.d. orally for 12 months
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Abnormal on skin and its subsidiary tissues
|
6.0%
7/117
Safety Population
|
4.2%
5/118
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal system abnormalities
|
17.1%
20/117
Safety Population
|
15.3%
18/118
Safety Population
|
|
Nervous system disorders
Central and peripheral nervous system abnormalities
|
8.5%
10/117
Safety Population
|
7.6%
9/118
Safety Population
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
31.6%
37/117
Safety Population
|
27.1%
32/118
Safety Population
|
|
Hepatobiliary disorders
Abnormal liver system
|
6.0%
7/117
Safety Population
|
5.1%
6/118
Safety Population
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
6.8%
8/117
Safety Population
|
2.5%
3/118
Safety Population
|
|
Cardiac disorders
Abnormal Cardiovascular system
|
13.7%
16/117
Safety Population
|
8.5%
10/118
Safety Population
|
|
Cardiac disorders
Heart rate and rhythm disorders
|
7.7%
9/117
Safety Population
|
6.8%
8/118
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory abnormalities
|
20.5%
24/117
Safety Population
|
29.7%
35/118
Safety Population
|
|
Renal and urinary disorders
Urinary system abnormalities
|
10.3%
12/117
Safety Population
|
10.2%
12/118
Safety Population
|
|
General disorders
Systemic anomalies
|
6.8%
8/117
Safety Population
|
5.1%
6/118
Safety Population
|
|
General disorders
Others
|
23.1%
27/117
Safety Population
|
21.2%
25/118
Safety Population
|
Additional Information
Takao Ishii, Asia regulatory affaires
Eisai Co., Ltd.
Phone: 81-3-3817-3914
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place