Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

NCT ID: NCT00097812

Last Updated: 2012-04-27

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women between 45 and 79 years of age
* Must be osteopenic/osteoporotic
* Treatment with oral bisphosphonate for at least 1 year

Exclusion Criteria

* Any woman of child bearing potential
* Treatment with other bone active agents
Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Permanente Medical Group

Santa Rosa, California, United States

Site Status

Colorado Center for Bone Research

Lakewood, Colorado, United States

Site Status

Florida Medical Research Institute

Gainsville, Florida, United States

Site Status

Radiant Research

Stuart, Florida, United States

Site Status

University of Kansas School of Medicine/ Division of Endocrinology

Kansas City, Kansas, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Arthritis Center of Nebraska

Lincoln, Nebraska, United States

Site Status

Creighton University Osteoporosis Research Center

Omaha, Nebraska, United States

Site Status

Oregon Osteoporosis Center

Portland, Oregon, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Radiant Research

Wyomissing, Pennsylvania, United States

Site Status

Puget Sound Osteoporosis Center

Seattle, Washington, United States

Site Status

Novartis

Nuremberg, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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CZOL446H2313

Identifier Type: -

Identifier Source: org_study_id

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