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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00100620

First received: January 3, 2005

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: Zoledronic Acid	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Osteoporosis Steroids

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.

Secondary Outcome Measures:

Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline
Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12
Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy

Estimated Enrollment:	802
Study Start Date:	June 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100620

Locations

United States, Alabama
Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders
Birmingham, Alabama, United States, 35294-3708
United States, Georgia
United Osteoporosis Centers
Gainesville, Georgia, United States, 30501
United States, Maryland
Osteoporosis & Clinical Trials
Cumberland, Maryland, United States, 21502
United States, Ohio
University of Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Radiant Research
Wyomissing, Pennsylvania, United States, 19610
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

Additional Information:

Patient e-portal for Novartis clinical trials This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00100620 History of Changes
Other Study ID Numbers:	CZOL446O2306
Study First Received:	January 3, 2005
Last Updated:	April 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Corticosteroid induced osteoporosis
prevention
treatment
zoledronic acid

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid

Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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