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.

Phase 4

Completed

• Conditions: Bone Loss
• Interventions: Drug: Pamidronate

• Registration Number: NCT00738257
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2004-12
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-14
• Last Update Posted: 2010-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parmidronate	Pamidronate	-

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Frimley, United Kingdom