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CompletedNCT00164008Updated Dec 5, 2013

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

A Phase 4 interventional study of zoledronic acid vs pamidronate in Osteopenia, Complications of Heart-lung Transplant and Other Complications of Lung Transplant, sponsored by Bayside Health. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-05.

Sponsored by Bayside Health · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteopenia
  • Complications of Heart-lung Transplant
  • Other Complications of Lung Transplant
03

In context

Bone Diseases, Metabolic

470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Bayside Health is the lead sponsor of 110 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • untreated hypogonadism, hypothyroidism or hyperthyroidism
  • acute or major organ rejection or intercurrent illness
  • pregnancy or breastfeeding
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Interventions

  • Drugzoledronic acid vs pamidronate
06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00164008
Lead sponsor
Bayside Health
Collaborators
Novartis
Responsible party
Sponsor
First posted
Sep 14, 2005
Start date
Oct 2002
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Dec 5, 2013

Study contacts

Duncan J Topliss, MD
principal investigator · The Alfred
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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