Assessment of two doses of Alendronate on the treament of osteopenia on menopaused females
Phase 2
- Conditions
- Osteopenia.Menopausal and other perimenopausal disorders
- Registration Number
- IRCT20190325043111N1
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 140
Inclusion Criteria
Menopausal state
Osteopenia (hip or spine T-score -2.5 to -1)
Normal serum levels of vitamin D, Calcium, Phosphorus, Alkaline phosphatase
Lacking history of pathological or traumatic fractures
Lacking the diagnosis of malignancy
Exclusion Criteria
The impossibility to determine FRAX index due to any reason
Osteoprosis (T-score worse than -2.5)
Osteopenia (hip or spine T-score -2.5 to -1) plus pathological fracture
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hip FRAX. Timepoint: Immediately before intervention and within 2 years following intervention. Method of measurement: Bone mineral densitometry.;Spine FRAX. Timepoint: Immediately before intervention and within 2 years following intervention. Method of measurement: Bone mineral densitometry.;Hip T-score. Timepoint: Immediately before intervention and within 2 years following intervention. Method of measurement: Bone mineral densitometry.;Spine T-score. Timepoint: Immediately before intervention and within 2 years following intervention. Method of measurement: Bone mineral densitometry.
- Secondary Outcome Measures
Name Time Method Hip Z-score. Timepoint: Immediately before intervention and within 2 years following intervention. Method of measurement: Bone mineral densitometry.;Spine Z-score. Timepoint: Immediately before intervention and within 2 years following intervention. Method of measurement: Bone mineral densitometry.