Overview
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Status:
Completed
Completed
Trial end date:
2009-11-01
2009-11-01
Target enrollment:
0
0
Participant gender:
Female
Female
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): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
NovartisTreatments:
Diphosphonates
Zoledronic Acid
Criteria
Inclusion Criteria:- Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.
Exclusion Criteria:
- 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.