Back to resultsComparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention
Primary Purpose
Osteopenia, Complications of Heart-lung Transplant, Other Complications of Lung Transplant
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
zoledronic acid vs pamidronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Bone mineral density of lumbar spine at 12 months as measured by DEXA.
Secondary Outcome Measures
Bone mineral density of femoral neck at 12 months as measured by DEXA.
Full Information
NCT ID
NCT00164008
First Posted
September 13, 2005
Last Updated
December 3, 2013
Sponsor
Bayside Health
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00164008
Brief Title
Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention
Official Title
Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Complications of Heart-lung Transplant, Other Complications of Lung Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zoledronic acid vs pamidronate
Primary Outcome Measure Information:
Title
Bone mineral density of lumbar spine at 12 months as measured by DEXA.
Secondary Outcome Measure Information:
Title
Bone mineral density of femoral neck at 12 months as measured by DEXA.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan J Topliss, MD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention
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