Effect of alendronate on spontaneous osteoclastogenesis in postmenopausal osteoporosis - ALENDRONATE
- Conditions
- MedDRA version: 6.1Level: PTClassification code 10031285postmenopausal osteoporosis
- Registration Number
- EUCTR2006-001796-37-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 30
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
Exclusion Criteria
a.legal or mental incapacity to give the informed consent; b. secondary osteoporosis; c. patients taking drugs active on bone metabolism d. patients taking immunosuppresant within the previous year e. previous adverse events with alendronate or calcium and vitamin D f. surgicall menopause g. history of cancer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;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 Outcome Measures
Name Time Method