EUCTR2006-006086-16-ESActive, not recruitingNot Applicable
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.Eficacia y seguridad de 2 g de ranelato de estroncio en el tratamiento de la osteoporosis en hombre. Estudio prospectivo, multicéntrico, internacional, doble ciego, controlado frente a placebo con una duración del tratamiento de 2 años y el análisis principal del estudio tras 1 año. - MALEO
aboratorios Servier S.L.0 sites221 target enrollmentStarted: October 25, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 221
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
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
- •- 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
Investigators
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