Trial Outcomes & Findings for Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients. (NCT NCT00266708)
NCT ID: NCT00266708
Last Updated: 2019-03-01
Results Overview
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
COMPLETED
PHASE1/PHASE2
60 participants
month 6 of the treatment
2019-03-01
Participant Flow
Transplant candidates from Montefiore Medical Centre were recruited for the study.
117 transplant candidates were identified as potentially eligible for the study. 57 of the 117 refused to participate and 60 of the candidates signed consent forms. Of the 60 who signed, 18 were either not transplanted or lost to follow-up so only 42 were randomized.
Participant milestones
| Measure |
Risedronate
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Risedronate
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Overall Study
No renal function
|
1
|
1
|
|
Overall Study
Refused biopsy
|
3
|
6
|
|
Overall Study
Asthma
|
0
|
2
|
Baseline Characteristics
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
Baseline characteristics by cohort
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 11 • n=99 Participants
|
48 years
STANDARD_DEVIATION 14 • n=107 Participants
|
44.7 years
STANDARD_DEVIATION 12.42 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
22 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
BMD Calcium - Spine
|
1.01 gm/cm^2
STANDARD_DEVIATION 0.17 • n=99 Participants
|
1.01 gm/cm^2
STANDARD_DEVIATION 0.17 • n=107 Participants
|
1.01 gm/cm^2
STANDARD_DEVIATION 0.17 • n=206 Participants
|
|
BMD Calcium - Hip
|
0.90 gm/cm^2
STANDARD_DEVIATION 0.15 • n=99 Participants
|
0.92 gm/cm^2
STANDARD_DEVIATION 0.17 • n=107 Participants
|
0.909 gm/cm^2
STANDARD_DEVIATION 0.16 • n=206 Participants
|
|
BMD Calcium - Forearm
|
0.54 gm/cm^2
STANDARD_DEVIATION 0.09 • n=99 Participants
|
0.61 gm/cm^2
STANDARD_DEVIATION 0.09 • n=107 Participants
|
0.57 gm/cm^2
STANDARD_DEVIATION 0.09 • n=206 Participants
|
PRIMARY outcome
Timeframe: month 6 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
Outcome measures
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Mineral Density of Spine at 6 Months
|
0.98 gm/cm^2
Standard Deviation 0.16
|
0.97 gm/cm^2
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: month 12 of treatmentPopulation: Calculation done on intent-to-treat population
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.
Outcome measures
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Mineral Density of Spine at 12 Months
|
1.00 gm/cm^2
Standard Deviation 0.18
|
1.00 gm/cm^2
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: month 6 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Outcome measures
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Mineral Density of the Hip at 6 Months
|
0.88 gm/cm^2
Standard Deviation 0.13
|
0.86 gm/cm^2
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Outcome measures
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Mineral Density of the Hip at 12 Months
|
0.91 gm/cm^2
Standard Deviation 0.13
|
0.87 gm/cm^2
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: month 6 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Outcome measures
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Mineral Density of Forearm at 6 Months
|
0.57 gm/cm^2
Standard Deviation 0.11
|
0.58 gm/cm^2
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Outcome measures
| Measure |
Risedronate
n=20 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Mineral Density of Forearm at 12 Months
|
0.55 gm/cm^2
Standard Deviation 0.12
|
0.58 gm/cm^2
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Bone Volume is the percentage of total volume occupied by calcified bone. Percent Bone volume is calculated as Bone Volume (BV) divided by Tissue Volume (TV), where TV is bone plus marrow.
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Bone Volume (BV/TV)
Baseline
|
10.7 percent
Standard Deviation 6
|
13.3 percent
Standard Deviation 9
|
|
Bone Histomorphometry - Percent Bone Volume (BV/TV)
month 12
|
11.3 percent
Standard Deviation 5
|
9.7 percent
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. The ends of certain bones, known as cancellous bones, are actually not solid but are full of holes that are connected to each other by thin rods and plates of bone tissue known as trabeculae. Trabeculae of bone provide structural support to the spongy bone found at the ends of long bones. Trabeculae Trabecular Thickness (TbTh), a structural parameter, is the distance across individual trabecula.
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Trabecular Thickness (TbTh)
Baseline
|
72.6 micron
Standard Deviation 17
|
90.9 micron
Standard Deviation 39
|
|
Bone Histomorphometry - Trabecular Thickness (TbTh)
month 12
|
72.1 micron
Standard Deviation 28
|
62.2 micron
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Mineralized Bone Volume is the percentage of Bone Volume consisting of mineralized bone. Percent Mineralized Bone Volume is calculated as Mineralized Bone Volume (MdV) divided by Bone Volume (BV).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
Baseline
|
95 percent
Standard Deviation 3
|
95 percent
Standard Deviation 4
|
|
Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
month 12
|
92 percent
Standard Deviation 7
|
96 percent
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Bone mineralization is the process of laying down minerals on the matrix of the bone, with calcium and phosphorus as the most abundant minerals. Mineralized Bone Volume (MdV) is the percentage of mineralized bone tissue.
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Mineralized Bone Volume (MdV)
Baseline
|
1.2 percent
Standard Deviation 0.4
|
1.3 percent
Standard Deviation 1
|
|
Bone Histomorphometry - Mineralized Bone Volume (MdV)
month 12
|
1.2 percent
Standard Deviation 0.5
|
1.0 percent
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of bone that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Bone Volume (BV).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
Baseline
|
4.1 percent
Standard Deviation 2.6
|
4.6 percent
Standard Deviation 3.4
|
|
Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
month 12
|
8.7 percent
Standard Deviation 7.2
|
4.9 percent
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of tissue (bone + marrow) that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Tissue Volume (TV).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
Baseline
|
0.49 percent
Standard Deviation 0.4
|
0.58 percent
Standard Deviation 0.58
|
|
Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
month 12
|
0.90 percent
Standard Deviation 0.8
|
0.51 percent
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of bone surface that consists of unmineralized bone. It is equal to Osteoid Surface (OS) divided by Bone Surface (BS).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
Baseline
|
23 percent
Standard Deviation 18
|
15 percent
Standard Deviation 8
|
|
Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
month 12
|
24 percent
Standard Deviation 27
|
14 percent
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone mass is a balance between the osteoblasts (OB) that form the bone and cells called osteoclasts (OC) that break down the bone. The reported values indicate the percent of bone surface (BS) that is made up of osteoblasts (OB).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
Baseline
|
2.3 percent
Standard Deviation 3
|
1.3 percent
Standard Deviation 1.3
|
|
Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
month 12
|
1.23 percent
Standard Deviation 1.6
|
0.75 percent
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secrete digestive enzymes that break up or dissolve the bone tissue. Bone mass is a balance between the osteoblasts (OB) cells that form the bone and the osteoclasts (OC) cells that break down the bone. The reported values indicate the percent of bone surface (BS) that consists of osteoclasts (OC).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=16 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
Baseline
|
1.5 percent
Standard Deviation 1.9
|
0.97 percent
Standard Deviation 1.2
|
|
Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
month 12
|
0.28 percent
Standard Deviation 0.43
|
0.68 percent
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secret digestive enzymes tha break up or dissolve the bone tissue. An eroded surface (ES) is the surface of the lacuna ( a cavity or depression in the bone) generated by an active OC. The reported values indicate the percent of eroded surface relative to bone surface (BS).
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
Baseline
|
9 percent
Standard Deviation 11
|
1.36 percent
Standard Deviation 1.7
|
|
Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
month 12
|
2.7 percent
Standard Deviation 3
|
0.82 percent
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone formation rate (BFR) indicates how much of the bone is actively mineralizing; it is determined by the number of active OB and the average work of each OB.
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Bone Formation Rate
Baseline
|
0.02 micron/day
Standard Deviation 0.05
|
0.04 micron/day
Standard Deviation 0.1
|
|
Bone Histomorphometry - Bone Formation Rate
month 12
|
0.10 micron/day
Standard Deviation 0.16
|
0.05 micron/day
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline and month 12 of the treatmentPopulation: Calculation done on intent-to-treat population
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the Osteoid Volume (OV), the volume of bone that consists of unmineralized bone.
Outcome measures
| Measure |
Risedronate
n=16 Participants
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=13 Participants
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Bone Histomorphometry - Osteoid Volume (OV)
Baseline
|
0.06 micron^3
Standard Deviation 0.04
|
0.06 micron^3
Standard Deviation 0.06
|
|
Bone Histomorphometry - Osteoid Volume (OV)
month 12
|
0.10 micron^3
Standard Deviation 0.09
|
0.03 micron^3
Standard Deviation 0.02
|
Adverse Events
Risedronate
Placebo
Serious adverse events
| Measure |
Risedronate
n=20 participants at risk
subjects received Risedronate for one year
Risedronate 35 Mg: risedronate 35 mg weekly
|
Placebo
n=22 participants at risk;n=20 participants at risk
subjects received placebo for 1 year
Placebo weekly
|
|---|---|---|
|
Vascular disorders
deep venous thrombosis
|
5.0%
1/20 • Number of events 1 • Adverse events collected during course of study, which lasted 6 years.
|
0.00%
0/20 • Adverse events collected during course of study, which lasted 6 years.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place