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NCT00738257 Clinical Trial

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.

Bone Loss Clinical Trial

— SMART  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00738257
Other study ID # NEO-GB-50
Secondary ID ARE-GB-01
Status Completed
Phase Phase 4
First received August 18, 2008
Last updated May 14, 2010
Start date June 2000

Study information
Verified date May 2010
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pamidronate

Locations
Country Name City State
United Kingdom Novartis Investigative Site Frimley

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

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