Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
NCT ID: NCT00145327
Last Updated: 2011-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2456 participants
INTERVENTIONAL
2005-05-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zoledronic Acid 6
Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
Zoledronic Acid
Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
Zoledronic Acid 3 Placebo 3
Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
Placebo
100 mL physiologic 0.9% normal saline for intravenous infusion.
Placebo 3 Zoledronic Acid 3
Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
Zoledronic Acid
Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
Interventions
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Zoledronic Acid
Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
Placebo
100 mL physiologic 0.9% normal saline for intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
* Abnormal calcium levels in the blood
68 Years
90 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Sponsor GmbH
Locations
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Southern Arizona VA
Tucson, Arizona, United States
University of Arkansas for Medical Science
Little Rock, Arkansas, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Osteoporosis Prevention Center
San Diego, California, United States
Diablo Clinical Research, Inc
Walnut Creek, California, United States
Colorado Center for Bone Research
Lakewood, Colorado, United States
CRIA Research
Fort Lauderdale, Florida, United States
Radiant Research
Stuart, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
United Osteoporosis Centers (UOC)
Gainesville, Georgia, United States
Northwestern University Center for Clinical Research
Chicago, Illinois, United States
School of Medicine
Indianapolis, Indiana, United States
Medical Specialist Clinical Research Center
Munster, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Maine Center for Osteoporosis Research and Education
Bangor, Maine, United States
Osteoporosis Clinical Trial Center
Hagerstown, Maryland, United States
Clinical Pharmacology Study Groups
Worcester, Massachusetts, United States
Washington University Center for Clinical Studies
St Louis, Missouri, United States
New Mexico Clinical Research and Osteoporosis Center Inc
Albuquerque, New Mexico, United States
Winthrop U Hospital
Mineola, New York, United States
Odyssey Research Services/CCRC Internal Medical
Fargo, North Dakota, United States
University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Radiant Research
Wyomissing, Pennsylvania, United States
Rhode Island Hospital, Endocrinology Clinical Research Unit
Providence, Rhode Island, United States
University of Tennessee Health Science
Memphis, Tennessee, United States
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
VA Commonwealth University
Richmond, Virginia, United States
Puget Sound Osteoporosis Center
Seattle, Washington, United States
Novartis
Nuremberg, , Germany
Countries
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References
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Eastell R, Boonen S, Cosman F, Reid IR, Palermo L, Cummings SR, Black DM. Relationship between pretreatment rate of bone loss and bone density response to once-yearly ZOL: HORIZON-PFT extension study. J Bone Miner Res. 2015 Mar;30(3):570-4. doi: 10.1002/jbmr.2361.
Black DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, Cummings SR, Hue TF, Lippuner K, Lakatos P, Leung PC, Man Z, Martinez RL, Tan M, Ruzycky ME, Su G, Eastell R. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012 Feb;27(2):243-54. doi: 10.1002/jbmr.1494.
Other Identifiers
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CZOL446H2301E1
Identifier Type: -
Identifier Source: org_study_id
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