male osteoporosis MedDRA version: 9.1 Level: PT Classification code 10031282 Term: Osteoporosis
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 | — |
Countries
Belgium, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed