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

Bayside Health

Status and phase: Completed; Phase 4

Conditions: Osteopenia; Other Complications of Lung Transplant; Complications of Heart-lung Transplant

Treatments: Drug: zoledronic acid vs pamidronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00164008

101/02

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)