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

Osteopenia Clinical Trial

Official title:

Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164008
• Other study ID #: 101/02
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: December 3, 2013
• Start date: October 2002
• Est. completion date: December 2005

Study information

• Verified date: September 2005
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications of Heart-lung Transplant
• Osteopenia
• Other Complications of Lung Transplant

Intervention

Drug:
• zoledronic acid vs pamidronate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density of lumbar spine at 12 months as measured by DEXA.
Secondary	Bone mineral density of femoral neck at 12 months as measured by DEXA.