Status:
COMPLETED
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.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Bone Loss
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 glucocorticoi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00738257
Start Date
June 1 2000
Last Update
May 17 2010
Active Locations (1)
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1
Novartis Investigative Site
Frimley, United Kingdom