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

Tracking Information
First Received Date ^ICMJE	November 24, 2009
Last Updated Date	December 2, 2009
Start Date ^ICMJE	January 2006
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2009)	DEXA QDR 2000, Hologic Co. [ Time Frame: 1, 12, 24 and 48 weeks after operation ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01020253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Bone Density Arthroplasty, Replacement, Hip
Intervention ^ICMJE	Drug: alendronate, alfacalcidol Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
Study Arm (s)	Active Comparator: Alendronate medication Intervention: Drug: alendronate, alfacalcidol Active Comparator: Alfacalcidol medication Intervention: Drug: alendronate, alfacalcidol No Intervention: Non-medication Intervention: Drug: alendronate, alfacalcidol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	60
Completion Date	Not Provided
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	44 Years to 82 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01020253
Other Study ID Numbers ^ICMJE	YCU07-122
Has Data Monitoring Committee	No
Responsible Party	Naoyuki Iwamoto, Yokohama City University
Study Sponsor ^ICMJE	Yokohama City University Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yokohama City University Medical Center
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top