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: 6.1Level: PTClassification code 10031282

• Registration Number: EUCTR2006-006086-16-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-15
• Last Update Posted: 18 September 2012

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 0.743g/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