The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)

Arthroplasty, Replacement, Hip Clinical Trial

— ETOD  

Official title:

A Comparison of Alendronate vs. Alfacalcidol Medication for the Preservation of Bone Mineral Density Around the Femoral Implant and in the Lumbar Spine After a Total Hip Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01020253
• Other study ID #: YCU07-122
• Status: Active, not recruiting
• Phase: N/A
• First received: November 24, 2009
• Last updated: December 2, 2009
• Start date: January 2006

Study information

• Verified date: December 2009
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 44 Years to 82 Years

Eligibility

Inclusion Criteria:

• osteoarthritis of the hip

• patients after total hip arthroplasty

Exclusion Criteria:

• diseases related to bone metabolism

• patients taking drugs which affect bone metabolism

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Bone Density

Intervention

Drug:
• alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1µg per day, Tablet, Duration is 48 weeks.

Locations

Country	Name	City	State
Japan	Department of orthopaedic surgery, Yokohama City University	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DEXA QDR 2000, Hologic Co.		1, 12, 24 and 48 weeks after operation	Yes