Osteoporosis
Conditions
Keywords
Male Osteoporosis
Brief summary
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.
Interventions
DRUGZoledronic Acid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
25 Years to 85 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Canada, United States
Outcome results
None listed