Overview

This trial is active, not recruiting.

Conditions bone density, arthroplasty, replacement, hip
Treatment alendronate, alfacalcidol
Sponsor Yokohama City University Medical Center
Start date January 2006
End date April 2008
Trial size 60 participants
Trial identifier NCT01020253, YCU07-122

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
(Active Comparator)
alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
(No Intervention)
alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.

Primary Outcomes

Measure
DEXA QDR 2000, Hologic Co.
time frame: 1, 12, 24 and 48 weeks after operation

Eligibility Criteria

Male or female participants from 44 years up to 82 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Yokohama City University Medical Center.