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

NCT ID: NCT01020253

Last Updated: 2009-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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

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Conditions

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Bone Density Arthroplasty, Replacement, Hip

Keywords

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bisphosphonate, vitamin D3 Total Hip arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Alendronate medication

Group Type ACTIVE_COMPARATOR

alendronate, alfacalcidol

Intervention Type DRUG

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

Alfacalcidol medication

Group Type ACTIVE_COMPARATOR

alendronate, alfacalcidol

Intervention Type DRUG

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

Non-medication

Group Type NO_INTERVENTION

alendronate, alfacalcidol

Intervention Type DRUG

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

Interventions

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alendronate, alfacalcidol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

44 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yokohama City University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yokohama City University

Locations

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Department of orthopaedic surgery, Yokohama City University

Yokohama, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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YCU07-122

Identifier Type: -

Identifier Source: org_study_id