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

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.

Official Title

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

Conditions

Osteoporosis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• 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 Outcome Measures:

• 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

Study Start

April 2004

Eligibility & Criteria

• Ages Eligible for Study: 25 Years – 85 Years
• Genders Eligible for Study: Male

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

Total Enrolment

288

Contact Details

• Garvan Institute of Medical Research, Sydney, New South Wales, 2010, Australia
• Repatriation General Hospital, Daw Park, South Australia, 5041, Australia
• Keogh Institute for Medical Research, Nedlands, Western Australia, 6009, Australia