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 个研究点目标入组 221 人开始时间: 2007年10月25日最近更新: 2012年9月18日

适应症

试验速览

暂无简介。

•. 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

•- 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

发起方

aboratorios Servier S.L.