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

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ClinicalTrials.gov Identifier: NCT01020253
Recruitment Status : Unknown
Verified December 2009 by Yokohama City University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2009
Last Update Posted : December 3, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Bone Density Arthroplasty, Replacement, Hip Drug: alendronate, alfacalcidol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2006
Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. DEXA QDR 2000, Hologic Co. [ Time Frame: 1, 12, 24 and 48 weeks after operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   44 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020253


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

Responsible Party: Naoyuki Iwamoto, Yokohama City University
ClinicalTrials.gov Identifier: NCT01020253     History of Changes
Other Study ID Numbers: YCU07-122
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009

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

Additional relevant MeSH terms:
Alfacalcidol
Alendronate
Hydroxycholecalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances