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

Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00164008
Enrollment
56
Registered
2005-09-14
Start date
2002-10-31
Completion date
2005-12-31
Last updated
2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGzoledronic acid vs pamidronate

Sponsors

Novartis
CollaboratorINDUSTRY
Bayside Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026