A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Pamidronate

Criteria

Inclusion Criteria:

1. First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml

2. De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.

Exclusion Criteria:

1. Previous or current bone disease unrelated to end stage renal failure.

2. Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.

3. Treatment at any time with a bisphosphonate.

4. d. Calcitonin treatment during the previous month.

5. Malignancy (current or history within last 5 years)

6. Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.

Protocol-defined inclusion/exclusion criteria may apply.