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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
- First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
- De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.
Exclusion Criteria
- Previous or current bone disease unrelated to end stage renal failure.
- Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
- Treatment at any time with a bisphosphonate.
- d. Calcitonin treatment during the previous month.
- Malignancy (current or history within last 5 years)
- 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 -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Frimley, United Kingdom