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

NCT00266708 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 02-08-224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Osteodystrophy

Keywords

renal transplant; post-transplant osteoporosis

Outcome Measures

Primary Outcomes (6)

• Bone Mineral Density of Spine at 6 Months

  Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.

  month 6 of the treatment

• Bone Mineral Density of Spine at 12 Months

  Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.

  month 12 of treatment

• Bone Mineral Density of the Hip at 6 Months

  Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.

  month 6 of the treatment

• Bone Mineral Density of the Hip at 12 Months

  Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.

  month 12 of the treatment

• Bone Mineral Density of Forearm at 6 Months

  Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.

  month 6 of the treatment

• Bone Mineral Density of Forearm at 12 Months

  Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.

  month 12 of the treatment

Secondary Outcomes (12)

• Bone Histomorphometry - Percent Bone Volume (BV/TV)

  Baseline and month 12 of the treatment

• Bone Histomorphometry - Trabecular Thickness (TbTh)

  Baseline and month 12 of the treatment

• Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)

  Baseline and month 12 of the treatment

• Bone Histomorphometry - Mineralized Bone Volume (MdV)

  Baseline and month 12 of the treatment

• Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)

  Baseline and month 12 of the treatment

Study Arms (2)

Risedronate

EXPERIMENTAL

subjects received Risedronate for one year

Drug: Risedronate

subjects received placebo

PLACEBO COMPARATOR

subjects received placebo for 1 year

Drug: Placebo

Interventions

Risedronate DRUG

risedronate 35 mg weekly

Also known as: bisphosphonate

Risedronate

Placebo DRUG

Risedronate Placebo 35 mg weekly

Also known as: Risedronate placebo

subjects received placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 22797188 RESULT

MeSH Terms

Interventions

Risedronic Acid; Diphosphonates

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Maria Coco, MD
• Organization: Montefiore Medical Center

mcoco@montefiore.org

718-920-4136

Study Officials

• Maria Coco, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 19, 2005
• Study Start: October 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2019-02

Locations

US (1)