3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

Novartis

Status and phase: Completed; Phase 3

Conditions: Post-menopausal Osteoporosis

Treatments: Drug: Zoledronic acid; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718861

CZOL446H2301E2

2007-005383-27 (EudraCT Number)

Details and patient eligibility

About

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Enrollment: 190 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

190 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo administered intravenously.

Treatment:

Drug: Placebo

Zoledronic acid

Experimental group

Treatment:

Drug: Zoledronic acid