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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00738257
First received: August 18, 2008
Last updated: May 14, 2010
Last verified: May 2010
  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:

  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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738257

Locations
United Kingdom
Novartis Investigative Site
Frimley, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: John Cunningham, MD Royal London Hospital
  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 April 17, 2014