Use of Bisphosphonates in the Treatment of Osteopathy Aft... | NCT00302484

Studies
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

NCT00302484

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Jul 26, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Osteoporosis
Liver Transplantation

Interventions

Zoledronate

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 13, 2006

First Submission Date that Met QC Criteria

Mar 13, 2006

First Posted Date

Mar 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2006

Last Update Posted Date

Jul 26, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Zoledronate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
first bone fracture or death within 24 months after liver transplantation

Secondary Outcomes

Measure	Description	Time Frame
bone mineral density (pre-transplant, 6 and 12 months post-transplant)
serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ferdinand Mühlbacher, M.D.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Department of Surgery, Division of Transplantation		Vienna	State of Vienna	A-1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077211	Zoledronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided