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)

Novartis

Status and phase: Completed; Phase 4

Conditions: Bone Loss

Treatments: Drug: Pamidronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738257

ARE-GB-01

NEO-GB-50

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Parmidronate

Experimental group

Treatment:

Drug: Pamidronate