Status:
COMPLETED
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Post-menopausal Osteoporosis
Eligibility:
FEMALE
65+ years
Phase:
PHASE3
Brief Summary
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
Eligibility Criteria
Inclusion
- Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1
Exclusion
- Poor kidney, eye, liver health
- Use of certain therapies for osteoporosis in study CZOL446H2301E1
- Abnormal calcium levels
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00718861
Start Date
May 1 2008
End Date
April 1 2013
Last Update
October 9 2014
Active Locations (57)
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1
Novartis Investigative Site
San Diego, California, United States, 92103-6204
2
Novartis Investigative Site
Lakewood, Colorado, United States, 80227
3
Novartis Investigative Site
Gainesville, Georgia, United States, 30501
4
Novartis Investigative Site
Indiamapolis, Indiana, United States, 46202