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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)

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. Identifier: NCT00738257
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : May 17, 2010
Information provided by:

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2000
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Parmidronate Drug: Pamidronate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00738257

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United Kingdom
Novartis Investigative Site
Frimley, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
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Principal Investigator: John Cunningham, MD Royal London Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00738257    
Other Study ID Numbers: NEO-GB-50
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: May 17, 2010
Last Verified: May 2010
Keywords provided by Novartis:
Ciclosporin A,
bone mineral density,
fracture rates
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs