SMART: 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.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00738257

Collaborator

(none)

126

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss	Drug: Pamidronate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parmidronate	Drug: Pamidronate

Arm

Intervention/Treatment

Experimental: Parmidronate

Drug: Pamidronate

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
1. 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.