The efficacy and safety of 2g strontium ranelate in the treatment of osteoporosis in men. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.
- Conditions
- Osteoporosis in menMedDRA version: 9.1Level: PTClassification code 10031282Term: Osteoporosis
- Registration Number
- EUCTR2006-004717-17-EE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 221
· The following BMD criterion:
Mean lumbar spine BMD or femoral neck BMD or total femur BMD corresponding to a T-score lower than –2.5SD of the young healthy male reference population
OR
Mean lumbar spine BMD or femoral neck BMD or total femur BMD corresponding to a T-score lower than –1.5SD of the young healthy male reference population plus a prevalent low impact fracture during adulthood
· Caucasian males of at least 65 years of age (with no upper age limit)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
· Bone mineral density T-score below –4.0 at one or more of the measured sites
· More than two prevalent mild and/or moderate osteoporotic vertebral fractures
· Severe osteoporotic vertebral fracture
. Other criteria (detailed in the protocol)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of strontium ranelate over 1 year compared to placebo in men with osteoporosis on lumbar BMD;Secondary Objective: . To demonstrate the efficacy on hip BMD and bone markers and safety of strontium ranelate over 1year compared to placebo in men with osteoporosis<br>. A secondary analysis will be performed after a follow up period of an additional year of treatment;Primary end point(s): · Bone Mineral Density (BMD) at the lumbar spine
- Secondary Outcome Measures
Name Time Method