Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

NCT ID: NCT00097825

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

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-08-31

Brief Summary

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The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.

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

* Male, 25-85 years old

Exclusion Criteria

* Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
* History of severe liver, kidney or eye disease
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Catalina Pointe Clinical Research Inc.

Tucson, Arizona, United States

Site Status

Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Colorado Center for Bone Research

Lakewood, Colorado, United States

Site Status

Radiant Research

Stuart, Florida, United States

Site Status

United Osteoporosis Center

Gainesville, Georgia, United States

Site Status

Northwestern Center for Clinical Research

Chicago, Illinois, United States

Site Status

Mercy Arthritis and Osteoporosis Center

Des Moines, Iowa, United States

Site Status

St. Joseph Hospital

Bangor, Maine, United States

Site Status

Osteoporosis and Clinical Trials Center

Hagerstown, Maryland, United States

Site Status

New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, United States

Site Status

Helen Hayes Hospital

West Haverstraw, New York, United States

Site Status

UC Bone Health and Osteoporosis Center

Cincinnati, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Radiant Research

Wyomissing, Pennsylvania, United States

Site Status

Hampton Roads Center for Clinical Research

Norfolk, Virginia, United States

Site Status

McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

Garvan Institute of Medical Research

Sydney, New South Wales, Australia

Site Status

Repatriation General Hospital

Daw Park, South Australia, Australia

Site Status

Keogh Institute for Medical Research

Nedlands, Western Australia, Australia

Site Status

Clinical Research Center

Vancouver, British Columbia, Canada

Site Status

QEII HealthSciences Center

Halifax, Nova Scotia, Canada

Site Status

Charlton Medical Building

Hamilton, Ontario, Canada

Site Status

Centre De Recherche Clinique De Laval

Laval, Quebec, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Groupe de Recherche en Rhumatologie et Maladies Osseuses

Sainte-Foy, Quebec, Canada

Site Status

Saskatoon Osteoporosis Center

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Australia Canada

References

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Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.

Reference Type DERIVED
PMID: 21037195 (View on PubMed)

Related Links

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http://www.novartisclinicaltrials.com/etrials/searchTrial.do?t=i&trialID=291&diseaseID=33

For information regarding US facilities, click this hyperlink.

Other Identifiers

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CZOL446M2308

Identifier Type: -

Identifier Source: org_study_id

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