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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266708
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):
Maria Coco, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Renal Transplant Osteodystrophy Drug: risedronate 35 mg weekly vs placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
Study Start Date : October 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. differences in bone mineral density between the two arms [ Time Frame: baseline, 6 months and 12 months ]
    measurement of BMD

Secondary Outcome Measures :
  1. analyzing bone histomorphometry bewtween the two arms [ Time Frame: baseline and 12 months ]
    bone biopies at baseline and 12 months are compared between the two arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults with end stage renal disease who are undergoing living donor kidney transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00266708

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

Responsible Party: Maria Coco, Principal Investigator, Montefiore Medical Center Identifier: NCT00266708     History of Changes
Other Study ID Numbers: 02-08-224
First Posted: December 19, 2005    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs