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

Phase 4

Completed

• Conditions: Osteopenia; Other Complications of Lung Transplant; Complications of Heart-lung Transplant

• Registration Number: NCT00164008
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-14
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Bone mineral density of lumbar spine at 12 months as measured by DEXA.

Secondary Outcome Measures

Name	Time	Method
Bone mineral density of femoral neck at 12 months as measured by DEXA.