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

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Zoledronic Acid; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00145327

CZOL446H2301E1

Details and patient eligibility

About

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.

Enrollment: 2,456 patients

Sex: Female

Ages: 68 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,456 participants in 3 patient groups, including a placebo group

Zoledronic Acid 6

Experimental group

Description:

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.

Treatment:

Drug: Zoledronic Acid

Zoledronic Acid 3 Placebo 3

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Placebo 3 Zoledronic Acid 3

Experimental group

Description:

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.

Treatment:

Drug: Zoledronic Acid