Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

NCT00302484 | Unknown

• 1 other identifier: LTX-BISPHO-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• first bone fracture or death within 24 months after liver transplantation

Secondary Outcomes (3)

• bone mineral density (pre-transplant, 6 and 12 months post-transplant)

• serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)

• histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)

Interventions

Zoledronate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ferdinand Mühlbacher, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: April 1, 2002
• Last Updated: July 26, 2006

Record last verified: 2006-01

Locations

AU (1)