Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097825

CZOL446M2308

Details and patient eligibility

About

The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.

Sex: Male

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, 25-85 years old

Exclusion criteria

• Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
• History of severe liver, kidney or eye disease

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind