Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00302484
• Collaborator: (none)
• Enrollment: 96
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Liver Transplantation	Drug: Zoledronate	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
• Study Start Date: Apr 1, 2002

Outcome Measures

Primary Outcome Measures

1. first bone fracture or death within 24 months after liver transplantation []

Secondary Outcome Measures

1. bone mineral density (pre-transplant, 6 and 12 months post-transplant) []

2. serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone) []

3. histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Surgery, Division of Transplantation	Vienna		Austria	A-1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Ferdinand Mühlbacher, M.D., Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00302484
• Other Study ID Numbers: LTX-BISPHO-01
• First Posted: Mar 14, 2006
• Last Update Posted: Jul 26, 2006
• Last Verified: Jan 1, 2006

• Additional relevant MeSH terms: Osteoporosis; Zoledronic Acid

Study Results

No Results Posted as of Jul 26, 2006