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Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.

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ClinicalTrials.gov Identifier: NCT00266708
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Renal Transplant Osteodystrophy
Interventions Drug: Risedronate
Drug: Placebo
Enrollment 60
Recruitment Details Transplant candidates from Montefiore Medical Centre were recruited for the study.
Pre-assignment Details 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.
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Period Title: Overall Study
Started [1] 20 22
Completed 16 13
Not Completed 4 9
Reason Not Completed
No renal function             1             1
Refused biopsy             3             6
Asthma             0             2
[1]
Randomize
Arm/Group Title Risedronate Placebo Total
Hide Arm/Group Description

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Total of all reporting groups
Overall Number of Baseline Participants 20 22 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 22 participants 42 participants
42  (11) 48  (14) 44.7  (12.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 22 participants 42 participants
Female
9
  45.0%
6
  27.3%
15
  35.7%
Male
11
  55.0%
16
  72.7%
27
  64.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 22 participants 42 participants
African American
3
  15.0%
3
  13.6%
6
  14.3%
Hispanic
10
  50.0%
11
  50.0%
21
  50.0%
White
5
  25.0%
6
  27.3%
11
  26.2%
Other
2
  10.0%
2
   9.1%
4
   9.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 22 participants 42 participants
20 22 42
BMD Calcium - Spine  
Mean (Standard Deviation)
Unit of measure:  Gm/cm^2
Number Analyzed 20 participants 22 participants 42 participants
1.01  (0.17) 1.01  (0.17) 1.01  (0.17)
BMD Calcium - Hip  
Mean (Standard Deviation)
Unit of measure:  Gm/cm^2
Number Analyzed 20 participants 22 participants 42 participants
0.90  (0.15) 0.92  (0.17) 0.909  (0.16)
BMD Calcium - Forearm  
Mean (Standard Deviation)
Unit of measure:  Gm/cm^2
Number Analyzed 20 participants 22 participants 42 participants
0.54  (0.09) 0.61  (0.09) 0.57  (0.09)
1.Primary Outcome
Title Bone Mineral Density of Spine at 6 Months
Hide Description Bone Mineral Density (BMD) measurements were of the vertebral spine (L1–L4) measured using the Hologic 4500 QDC scanner.
Time Frame month 6 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: gm/cm^2
0.98  (0.16) 0.97  (0.14)
2.Primary Outcome
Title Bone Mineral Density of Spine at 12 Months
Hide Description Bone Mineral Density (BMD) measurements were of the vertebral spine (L1–L4) measured using same Hologic 4500 QDC scanner.
Time Frame month 12 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: gm/cm^2
1.00  (0.18) 1.00  (0.18)
3.Primary Outcome
Title Bone Mineral Density of the Hip at 6 Months
Hide Description Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Time Frame month 6 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: gm/cm^2
0.88  (0.13) 0.86  (0.13)
4.Primary Outcome
Title Bone Mineral Density of the Hip at 12 Months
Hide Description Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Time Frame month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: gm/cm^2
0.91  (0.13) 0.87  (0.15)
5.Primary Outcome
Title Bone Mineral Density of Forearm at 6 Months
Hide Description Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Time Frame month 6 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: gm/cm^2
0.57  (0.11) 0.58  (0.11)
6.Primary Outcome
Title Bone Mineral Density of Forearm at 12 Months
Hide Description Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Time Frame month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: gm/cm^2
0.55  (0.12) 0.58  (0.09)
7.Secondary Outcome
Title Bone Histomorphometry - Percent Bone Volume (BV/TV)
Hide Description 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.
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 10.7  (6) 13.3  (9)
month 12 11.3  (5) 9.7  (4)
8.Secondary Outcome
Title Bone Histomorphometry - Trabecular Thickness (TbTh)
Hide Description 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.
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: micron
Baseline 72.6  (17) 90.9  (39)
month 12 72.1  (28) 62.2  (20)
9.Secondary Outcome
Title Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 95  (3) 95  (4)
month 12 92  (7) 96  (6)
10.Secondary Outcome
Title Bone Histomorphometry - Mineralized Bone Volume (MdV)
Hide Description 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.
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 1.2  (0.4) 1.3  (1)
month 12 1.2  (0.5) 1.0  (0.5)
11.Secondary Outcome
Title Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 4.1  (2.6) 4.6  (3.4)
month 12 8.7  (7.2) 4.9  (5)
12.Secondary Outcome
Title Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 0.49  (0.4) 0.58  (0.58)
month 12 0.90  (0.8) 0.51  (0.8)
13.Secondary Outcome
Title Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 23  (18) 15  (8)
month 12 24  (27) 14  (10)
14.Secondary Outcome
Title Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 2.3  (3) 1.3  (1.3)
month 12 1.23  (1.6) 0.75  (0.76)
15.Secondary Outcome
Title Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 1.5  (1.9) 0.97  (1.2)
month 12 0.28  (0.43) 0.68  (1.23)
16.Secondary Outcome
Title Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
Hide Description 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).
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 9  (11) 1.36  (1.7)
month 12 2.7  (3) 0.82  (1.4)
17.Secondary Outcome
Title Bone Histomorphometry - Bone Formation Rate
Hide Description 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.
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: micron/day
Baseline 0.02  (0.05) 0.04  (0.1)
month 12 0.10  (0.16) 0.05  (0.06)
18.Secondary Outcome
Title Bone Histomorphometry - Osteoid Volume (OV)
Hide Description 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.
Time Frame Baseline and month 12 of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Calculation done on intent-to-treat population
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description:

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

Overall Number of Participants Analyzed 16 13
Mean (Standard Deviation)
Unit of Measure: micron^3
Baseline 0.06  (0.04) 0.06  (0.06)
month 12 0.10  (0.09) 0.03  (0.02)
Time Frame Adverse events collected during course of study, which lasted 6 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risedronate Placebo
Hide Arm/Group Description

subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly

subjects received placebo for 1 year

Placebo weekly

All-Cause Mortality
Risedronate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Risedronate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/20 (0.00%)    
Vascular disorders     
deep venous thrombosis * [1]  1/20 (5.00%)  1 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
venous thrombosis and Blood clots that develop in a vein, usually in the leg or thing. It can cause pain and swelling in the leg and may lead to complications such as pulmonary embolism.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Risedronate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/22 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maria Coco, MD
Organization: Montefiore Medical Center
Phone: 718-920-4136
Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00266708     History of Changes
Other Study ID Numbers: 02-08-224
First Submitted: December 15, 2005
First Posted: December 19, 2005
Results First Submitted: February 5, 2019
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019