Conditions: Osteoporosis
Keywords: Osteoporosis, Zoledronic Acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2456
Healthy volunteers: no

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): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

Detailed description:

Arms:
arm 1: Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment. arm 2: Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study. arm 3: Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion. intervention 2: 100 mL physiologic 0.9% normal saline for intravenous infusion.

Protocol document: