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Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention

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.
 
ClinicalTrials.gov Identifier: NCT00164008
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayside Health

Brief Summary:
The purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.

Condition or disease Intervention/treatment Phase
Osteopenia Complications of Heart-lung Transplant Other Complications of Lung Transplant Drug: zoledronic acid vs pamidronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis
Study Start Date : October 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Bone mineral density of lumbar spine at 12 months as measured by DEXA.

Secondary Outcome Measures :
  1. Bone mineral density of femoral neck at 12 months as measured by DEXA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • reduced bone density as indicated by a bone density T score <-1.in either the lumbar spine or femoral neck
  • have undergone or are on the waiting list for heart or lung transplantation
  • are receiving adequate calcium and vitamin D therapy
  • have provided written informed consent prior to participation in the trial

Exclusion Criteria:

  • untreated hypogonadism, hypothyroidism or hyperthyroidism
  • acute or major organ rejection or intercurrent illness
  • pregnancy or breastfeeding

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): NCT00164008


Sponsors and Collaborators
Bayside Health
Novartis
Investigators
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Principal Investigator: Duncan J Topliss, MD The Alfred
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Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00164008    
Other Study ID Numbers: 101/02
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: September 2005
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs