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Efficacy of Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant

NCT00657852 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2008-04-14

No results posted yet for this study

Summary

The aims of this study are to prospectively evaluate the efficacy of two intravenous infusions of pamidronate 90 mg, associated with calcium and calcidiol, in the early post-transplant period, on bone loss in liver transplant recipients, and to asses the safety of this treatment.

Conditions

  • Bone Disease, Metabolic

Interventions

DRUG

Disodium pamidronate

Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion

DRUG

Placebo

500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Miquel Navasa, Dr · Hospital Clinic i Provincial, Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2003-12-31
Completion
2003-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657852 on ClinicalTrials.gov