Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

Summary

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

Conditions

• Male Osteoporosis

Interventions

DRUG

Zoledronic acid 5 mg iv

Zoledronic acid 5 mg iv given once a year.

DRUG

Placebo

Placebo intravenous (i.v.) once a year

Sponsors & Collaborators

• Novartis Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Novartis Pharmaceuticals · Novartis Argentina

• Novartis Pharmaceuticals · Novartis Belgium

• Novartis Pharmaceuticals · Novartis Brazil

• Novartis Pharmaceuticals · Novartis Czech Republic

• Novartis Pharmaceuticals · Novartis Denmark

• Novartis Pharmaceuticals · Novartis Finland

• Novartis Pharmaceuticals · Novartis Germany

• Novartis Pharmaceuticals · Novartis Hungary

• Novartis Pharmaceuticals · Novartis Norway

• Novartis Pharmaceuticals · Novartis Portugal

• Novartis Pharmaceuticals · Novartis Romania

• Novartis Pharmaceuticals · Novartis Spain

• Novartis Pharmaceuticals · Novartis Slovakia

• Novartis Pharmaceuticals · Novartis Sweden

• Novartis Pharmaceuticals · Novartis

• Novartis Pharmaceuticals · Novartis United Kingdom

• Novartis Pharmaceuticals · Novartis Australia

• Novartis Pharmaceuticals · Novartis Italy

• Novartis Pharmaceuticals · Novartis Austria

• Novartis Pharmaceuticals · Novartis Iceland

• Novartis Pharmaceuticals · Novartis Poland

• Novartis Pharmaceuticals · Novartis Russia

• Novartis Pharmaceuticals · Novartis (South Africa)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-12-31

Primary Completion

2010-10-31

Completion

2010-10-31

Countries

• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Czechia
• Denmark
• Finland
• Germany
• Hungary
• Iceland
• Italy
• Norway
• Poland
• Portugal
• Romania
• Russia
• Slovakia
• South Africa
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations