The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis.A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year. - MALEO

• Conditions: male osteoporosis; MedDRA version: 9.1Level: PTClassification code 10031282Term: Osteoporosis

• Registration Number: EUCTR2006-006086-16-IE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-10
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 221

Inclusion Criteria

. The following BMD criterion:
- Mean lumbar spine BMD lower than 0.840g/cm² or femoral neck BMD lower than 0.600g/cm² measured by Hologic apparatus
OR
- Mean lumbar spine BMD lower than 0.949g/cm² or femoral neck BMD lower than 0.743 g/cm² measured by Lunar apparatus
. 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) yes
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

Exclusion Criteria

- 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 fractures

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 over 1 year of strontium ranelate compared to placebo on lumbar BMD in men with osteoporosis.;Secondary Objective: To demonstrate the efficacy on hip BMD and bone markers and safety of strontium ranelate over 1 year compared to placebo in men with osteoporosis. <br>To assess the efficacy of strontium ranelate compared to placebo over 2 years in men with osteoporosis.;Primary end point(s): Bone Mineral Density (BMD) of the lumbar spine