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

Novartis Pharmaceuticals288 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

288

Conditions

Osteoporosis

Interventions

Zoledronic AcidDRUG

Eligibility

Sex: MALEMin age: 25 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (26)

Outcomes

Primary Outcomes

To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Secondary Outcomes

To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline

Data from ClinicalTrials.gov

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