NCT00164008

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2002

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 5, 2013

Status Verified

September 1, 2005

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

December 3, 2013

Conditions

OsteopeniaComplications of Heart-lung TransplantOther Complications of Lung Transplant

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density of lumbar spine at 12 months as measured by DEXA.

Secondary Outcomes (1)

  • Bone mineral density of femoral neck at 12 months as measured by DEXA.

Interventions

zoledronic acid vs pamidronateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • untreated hypogonadism, hypothyroidism or hyperthyroidism
  • acute or major organ rejection or intercurrent illness
  • pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Duncan J Topliss, MD

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

October 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 5, 2013

Record last verified: 2005-09