Status:
COMPLETED
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Lead Sponsor:
Novartis
Conditions:
Osteoporosis
Eligibility:
FEMALE
68-90 years
Phase:
PHASE3
Brief Summary
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): HORIZ...
Eligibility Criteria
Inclusion
- Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
2456 Patients enrolled
Trial Details
Trial ID
NCT00145327
Start Date
May 1 2005
End Date
November 1 2009
Last Update
June 28 2011
Active Locations (31)
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1
Southern Arizona VA
Tucson, Arizona, United States, 85723
2
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
3
Osteoporosis Medical Center
Beverly Hills, California, United States, 90211
4
Osteoporosis Prevention Center
San Diego, California, United States, 92103