NCT00265252

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 27, 2008

Status Verified

April 1, 2007

First QC Date

December 12, 2005

Last Update Submit

February 26, 2008

Conditions

Non-Traumatic Osteonecrosis

Keywords

osteonecrosistotal hip replacement

Outcome Measures

Primary Outcomes (1)

  • the cumulative of total hip replacement

Secondary Outcomes (2)

  • necrotic area

  • Harris hip score

Interventions

AlendronateDRUG

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteonecrosis of femoral head
  • be able to provide singed informed consent

You may not qualify if:

  • prior bisphosphonate use
  • pregnant or lactating woman
  • bilateral hip replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 16203877BACKGROUND

  • 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.

    PMID: 22127729DERIVED

MeSH Terms

Conditions

Osteonecrosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Gwo-Jaw Wang, MD

    Kaohsiung Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 14, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2008

Last Updated

February 27, 2008

Record last verified: 2007-04

Locations

TW(1)