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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:
ClinicalTrials.gov Identifier:
NCT00738257
First Posted: August 20, 2008
Last Update Posted: May 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: May 17, 2010
Last Verified: May 2010

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors