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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Coco, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00266708
First received: December 15, 2005
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Renal Transplant Osteodystrophy
 Drug: risedronate 35 mg weekly vs placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • differences in bone mineral density between the two arms [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    measurement of BMD


Secondary Outcome Measures:
  • analyzing bone histomorphometry bewtween the two arms [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    bone biopies at baseline and 12 months are compared between the two arms


Enrollment: 60
Study Start Date: October 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bisphosphonate arm
subjects received bisphosphonate for one year
 Drug: risedronate 35 mg weekly vs placebo
Placebo Comparator: subjects received placebo
subjects received placebo for 1 year
 Drug: risedronate 35 mg weekly vs placebo

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 DEXA bone mineral density scans. Both groups undergo bone hormonal studies at regular intervals.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with end stage renal disease who are undergoing living donor kidney transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266708

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Maria Coco, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Maria Coco, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00266708     History of Changes
Other Study ID Numbers: 02-08-224
Study First Received: December 15, 2005
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
renal transplant
post-transplant osteoporosis

Additional relevant MeSH terms:
Risedronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013