Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

Osteoporosis Clinical Trial

Official title:

Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00302484
• Other study ID #: LTX-BISPHO-01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 13, 2006
• Last updated: July 25, 2006
• Start date: April 2002

Study information

• Verified date: January 2006
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation
• Osteoporosis

Intervention

Drug:
• Zoledronate

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Surgery, Division of Transplantation	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first bone fracture or death within 24 months after liver transplantation
Secondary	bone mineral density (pre-transplant, 6 and 12 months post-transplant)
Secondary	serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
Secondary	histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)