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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Yokohama City University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT01020253
First received: November 24, 2009
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

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


Condition Intervention
Bone Density
Arthroplasty, Replacement, Hip
 Drug: alendronate, alfacalcidol

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • DEXA QDR 2000, Hologic Co. [ Time Frame: 1, 12, 24 and 48 weeks after operation ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alendronate medication Drug: alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
Active Comparator: Alfacalcidol medication Drug: alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
No Intervention: Non-medication Drug: alendronate, alfacalcidol
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.

  Eligibility

Ages Eligible for Study:   44 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020253

Locations
Japan
Department of orthopaedic surgery, Yokohama City University
Yokohama, Kanagawa, Japan
Sponsors and Collaborators
Yokohama City University Medical Center
  More Information

No publications provided

Responsible Party: Naoyuki Iwamoto, Yokohama City University
ClinicalTrials.gov Identifier: NCT01020253     History of Changes
Other Study ID Numbers: YCU07-122
Study First Received: November 24, 2009
Last Updated: December 2, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Yokohama City University Medical Center:
bisphosphonate, vitamin D3
Total Hip arthroplasty

Additional relevant MeSH terms:
Hydroxycholecalciferols
1-hydroxycholecalciferol
Alendronate
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013