Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Brief Summary

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Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.

Detailed Description

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Conditions

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Osteoporosis Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Zoledronate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary liver transplantation
* retransplantation within two weeks
* written informed consent
* Age ≥ 18 years

Exclusion Criteria

* chronic kidney disease:
* Creatinine Clearance \< 35 ml/min or Serum Creatinine \> 2,5 mg/dl
* known hypersensitivity to Zoledronate, or any of the recipients of the drug
* bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ferdinand Mühlbacher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna, Department of Surgery, Division of Transplantation

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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LTX-BISPHO-01

Identifier Type: -

Identifier Source: org_study_id