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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zoledronic acid vs pamidronate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duncan J Topliss, MD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

101/02

Identifier Type: -

Identifier Source: org_study_id