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

NCT ID: NCT00164008

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

zoledronic acid vs pamidronate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Bayside Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duncan J Topliss, MD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Other Identifiers

101/02

Identifier Type: -

Identifier Source: org_study_id