Overview

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

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
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.