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.

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00738257

Acronym

SMART

Enrollment

126

Registered

2008-08-20

Start date

2000-06-30

Completion date

Unknown

Last updated

2010-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss

Keywords

Renal, transplant,, pamidronate,, ciclosporin,, Ciclosporin A,, steroids,, bone mineral density,, fracture rates, immunosuppressive, regimen

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.

Interventions

DRUGPamidronate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026