Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis

In brief

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

Key facts

Study ID

NCT00145327

Run by

Novartis

People needed

2456

Starts

2005-05-01

Expected to finish

2009-11-01

Last updated by the study team

2011-06-28

Who can join

Age: 68 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

You may not qualify if…

• Poor kidney, eye, or liver health
• Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
• Abnormal calcium levels in the blood
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.