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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

Tracking Information
First Submitted Date  ICMJE December 15, 2005
First Posted Date  ICMJE December 19, 2005
Results First Submitted Date  ICMJE February 5, 2019
Results First Posted Date  ICMJE March 1, 2019
Last Update Posted Date March 1, 2019
Study Start Date  ICMJE October 2002
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Bone Mineral Density of Spine at 6 Months [ Time Frame: month 6 of the treatment ]
    Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
  • Bone Mineral Density of Spine at 12 Months [ Time Frame: month 12 of treatment ]
    Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.
  • Bone Mineral Density of the Hip at 6 Months [ Time Frame: month 6 of the treatment ]
    Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
  • Bone Mineral Density of the Hip at 12 Months [ Time Frame: month 12 of the treatment ]
    Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
  • Bone Mineral Density of Forearm at 6 Months [ Time Frame: month 6 of the treatment ]
    Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
  • Bone Mineral Density of Forearm at 12 Months [ Time Frame: month 12 of the treatment ]
    Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
  • Changes in Bone Mineral Density
  • Differences in Bone turnover
Change History Complete list of historical versions of study NCT00266708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Bone Histomorphometry - Percent Bone Volume (BV/TV) [ Time Frame: Baseline and month 12 of the treatment ]
    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.
  • Bone Histomorphometry - Trabecular Thickness (TbTh) [ Time Frame: Baseline and month 12 of the treatment ]
    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.
  • Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Mineralized Bone Volume (MdV) [ Time Frame: Baseline and month 12 of the treatment ]
    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.
  • Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS) [ Time Frame: Baseline and month 12 of the treatment ]
    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).
  • Bone Histomorphometry - Bone Formation Rate [ Time Frame: Baseline and month 12 of the treatment ]
    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.
  • Bone Histomorphometry - Osteoid Volume (OV) [ Time Frame: Baseline and month 12 of the treatment ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
Official Title  ICMJE Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
Brief Summary

Patients with kidney failure have underlying bone disease at the time of transplant. Fractures of various bones can be as high as 22%. Medication required for the transplant plays a role in bone loss.

Bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown preservation of bone mineral density in renal transplant recipients, we have demonstrated that pamidronate, a second generation bisphosphonate, is associated with low bone turnover while still preserving bone mineral density. Improved bone mineral density is associated with decreased fracture risk in the general population, while low bone turnover may be associated with increased fracture in dialysis patients.

The purpose of this study is to determine whether risedronate, a third generation bisphosphonate, is effective in preserving bone density when given prophylactically following renal transplantation and whether it is associated with low bone turnover at one year following renal transplantation.

Detailed Description Participants who receive a living donor kidney transplant undergo a bone biopsy at the time of kidney transplant and after one year of protocol. Once adequate kidney function is established, both groups take by mouth a weekly capsule (the control group has a placebo; the treatment group has risedronate 35 mg). Both groups undergo baseline, 6 month and 12 month dual energy x-ray absorptiometry (DEXA) bone mineral density scans. Both groups undergo bone hormonal studies at regular intervals.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Renal Transplant Osteodystrophy
Intervention  ICMJE
  • Drug: Risedronate
    risedronate 35 mg weekly
    Other Name: bisphosphonate
  • Drug: Placebo
    Risedronate Placebo 35 mg weekly
    Other Name: Risedronate placebo
Study Arms  ICMJE
  • Experimental: Risedronate
    subjects received Risedronate for one year
    Intervention: Drug: Risedronate
  • Placebo Comparator: subjects received placebo
    subjects received placebo for 1 year
    Intervention: Drug: Placebo
Publications * Coco M, Pullman J, Cohen HW, Lee S, Shapiro C, Solorzano C, Greenstein S, Glicklich D. Effect of risedronate on bone in renal transplant recipients. J Am Soc Nephrol. 2012 Aug;23(8):1426-37. doi: 10.1681/ASN.2011060623. Epub 2012 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with end stage renal disease who are undergoing living donor kidney transplantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00266708
Other Study ID Numbers  ICMJE 02-08-224
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Coco, MD, MS Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP