Conditions: Male Osteoporosis
Keywords: Osteoporosis males vertebral fractures clinical fractures bone mineral density bone biomarkers zoledronic acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1199
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year. arm 2: 100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Interventions: intervention 1: Zoledronic acid 5 mg iv intervention 2: Placebo
Intervention descriptions: intervention 1: Zoledronic acid 5 mg iv given once a year. intervention 2: Placebo intravenous (i.v.) once a year

Protocol document: