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

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: October 24, 2005 History of Changes

Sponsors and Collaborators:	Bayside Health Novartis
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00164008

Purpose

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.

Condition	Intervention	Phase
Osteopenia Heart Transplantation Lung Transplantation	Drug: zoledronic acid vs pamidronate	Phase IV

MedlinePlus related topics: Heart Transplantation Lung Transplantation Minerals

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis

Further study details as provided by Bayside Health:

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.

Estimated Enrollment:	80
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164008

Sponsors and Collaborators

Bayside Health

Novartis

Investigators

Principal Investigator:

Duncan J Topliss, MD

The Alfred Hospital

More Information

No publications provided

Study ID Numbers:	101/02
Study First Received:	September 13, 2005
Last Updated:	October 24, 2005
ClinicalTrials.gov Identifier:	NCT00164008 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Pamidronate

Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Pamidronate

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009