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. (SMART)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00738257
First received: August 18, 2008
Last updated: May 14, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Loss |
Drug: Pamidronate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 2 Year 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 (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen. |
Resource links provided by NLM:
Further study details as provided by Novartis:
| Enrollment: | 126 |
| Study Start Date: | June 2000 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Parmidronate | Drug: Pamidronate |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00738257 History of Changes |
| Other Study ID Numbers: | NEO-GB-50, ARE-GB-01 |
| Study First Received: | August 18, 2008 |
| Last Updated: | May 14, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Renal transplant, pamidronate, ciclosporin, Ciclosporin A, |
steroids, bone mineral density, fracture rates immunosuppressive regimen |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Immunosuppressive Agents Pamidronate Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunologic Factors |
Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 23, 2013