Effect of alendronate on spontaneous osteoclastogenesis in postmenopausal osteoporosis - ALENDRONATE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001796-37-IT

Enrollment

Registered

2006-05-25

Start date

2006-06-07

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal osteoporosis MedDRA version: 6.1 Level: PT Classification code 10031285

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026