Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

NCT ID: NCT00100620

Last Updated: 2017-05-17

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

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-04-30

Brief Summary

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The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.

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

* Long duration treatment with corticosteroids (started or ongoing)

Exclusion Criteria

* History of osteogenesis imperfecta, multiple myeloma or Paget's disease
* History of Hyperparathyroidism, hyperthyroidism
* History of Osteomalacia
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

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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Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders

Birmingham, Alabama, United States

Site Status

United Osteoporosis Centers

Gainesville, Georgia, United States

Site Status

Osteoporosis & Clinical Trials

Cumberland, Maryland, United States

Site Status

University of Ohio

Columbus, Ohio, United States

Site Status

Radiant Research

Wyomissing, Pennsylvania, United States

Site Status

McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Devogelaer JP, Sambrook P, Reid DM, Goemaere S, Ish-Shalom S, Collette J, Su G, Bucci-Rechtweg C, Papanastasiou P, Reginster JY. Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids. Rheumatology (Oxford). 2013 Jun;52(6):1058-69. doi: 10.1093/rheumatology/kes410. Epub 2013 Jan 30.

Reference Type DERIVED
PMID: 23365149 (View on PubMed)

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)

Reid DM, Devogelaer JP, Saag K, Roux C, Lau CS, Reginster JY, Papanastasiou P, Ferreira A, Hartl F, Fashola T, Mesenbrink P, Sambrook PN; HORIZON investigators. Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2009 Apr 11;373(9671):1253-63. doi: 10.1016/S0140-6736(09)60250-6.

Reference Type DERIVED
PMID: 19362675 (View on PubMed)

Other Identifiers

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CZOL446O2306

Identifier Type: -

Identifier Source: org_study_id

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