Effect of alendronate on spontaneous osteoclastogenesis in postmenopausal osteoporosis

INTERVENTION: Trade Name: FOSAMAX 70 70 MG 4 CPR Pharmaceutical Form: Tablet INN or Proposed INN: Alendronic acid CAS Number: 121268‐17‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 70‐ CONDITION: postmenopausal osteoporosis ; MedDRA version: 6.1 Level: PT Classification code 10031285 PRIMARY OUTCOME: Main Objective: to study the effect of in vivo alendronate 70 mg once/weekly in vitro on spontaneous osteoclastogenesis in postmenopausal osteoporosis Primary end point(s): to study the effect of in vivo alendronate 70 mg once/weekly in vitro on spontaneous osteoclastogenesis in postmenopausal osteoporosis Secondary Objective: to study the effect of calcium plus vitamin D on spontaneous osteoclastogenesis; to study the in vitro formation of osteoclasts in relation with circulating precursors and/or cytokine from PBMC before and after alendronate INCLUSION CRITERIA: a. T‐score ‐2.5 S.D. accrodng to WHO criteria with or without fractures; b. women in menopause since 1 year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no 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