Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Loss of bone mass is a common complication in patients with end-stage-renal failure, both before and particularly after transplantation. In addition to standard underlying therapy with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate) versus placebo on bone mineral density as well as incidence of fracture rates after kidney transplantation.We also wish to study whether any prevented bone loss will also lead to reduced cardiovascular disease. Patients will be followed for 12 months after transplantation, and the ibandronate treatment is one injection every 3 months.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Smerud Medical Research International AS
• Collaborator: Oslo University Hospital
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

Inclusion Criteria:

• Renal transplant recipients

• Adults, ≥ 18 years of age

• Either gender

• Signed informed consent

Exclusion Criteria:

• Persisting s-Ca > 2.55 mmol/L (through the first two weeks after transplantation)

• Impaired graft functioning (estimated GFR <30 ml/min)

• Previous (within the last 12 months) treatment with bisphosphonates, sodium fluoride, calcitonin, strontium, PTH, SERM, growth hormone or anabolic steroids at any time before transplantation.

• Known adynamic bone disease

• Previous parathyroidectomy

• Pregnant or lactating females or females of childbearing potential who do not use an approved method of contraception (oral contraceptives or IUD); positive urine pregnancy test, where applicable.

• Use of any investigational drug (s) and/or device(s)

• Previous participation in this trial

• History of hypersensitivity to bisphosphonates