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Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

Primary Purpose

Non-Traumatic Osteonecrosis

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Alendronate

About this trial

This is an interventional prevention trial for Non-Traumatic Osteonecrosis focused on measuring osteonecrosis, total hip replacement

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: osteonecrosis of femoral head be able to provide singed informed consent Exclusion Criteria: prior bisphosphonate use pregnant or lactating woman bilateral hip replacement

Sites / Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcomes

Primary Outcome Measures

the cumulative of total hip replacement

Secondary Outcome Measures

necrotic area

Harris hip score

Full Information

NCT ID

NCT00265252

First Posted

December 12, 2005

Last Updated

February 26, 2008

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

Merck Sharp & Dohme LLC, National Cheng-Kung University Hospital, National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00265252

Brief Title

Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

Official Title

Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

Merck Sharp & Dohme LLC, National Cheng-Kung University Hospital, National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary

To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid

Detailed Description

To determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with Fosamax or placebo during the study peroid

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Traumatic Osteonecrosis

Keywords

osteonecrosis, total hip replacement

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alendronate

Primary Outcome Measure Information:

Title

the cumulative of total hip replacement

Secondary Outcome Measure Information:

Title

necrotic area

Title

Harris hip score

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: osteonecrosis of femoral head be able to provide singed informed consent Exclusion Criteria: prior bisphosphonate use pregnant or lactating woman bilateral hip replacement

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gwo-Jaw Wang, MD

Organizational Affiliation

Kaohsiung Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

16203877

Citation

Lai KA, Shen WJ, Yang CY, Shao CJ, Hsu JT, Lin RM. The use of alendronate to prevent early collapse of the femoral head in patients with nontraumatic osteonecrosis. A randomized clinical study. J Bone Joint Surg Am. 2005 Oct;87(10):2155-9. doi: 10.2106/JBJS.D.02959.

Results Reference

background

PubMed Identifier

22127729

Citation

Chen CH, Chang JK, Lai KA, Hou SM, Chang CH, Wang GJ. Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.

Results Reference

derived

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Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

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