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Completed

NCT Number: NCT00164008

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

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Complications of Heart-lung Transplant Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Other Complications of Lung Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zoledronic acid vs pamidronate

Drug

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.

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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