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Assessment of two doses of Alendronate on the treament of osteopenia on menopaused females

The effect of two different doses of Alendronate on the treatment of osteopenia based on fracture risk assessment (FRAX) in menopauses women who referred to Alzahra hospital during 2014-17

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190325043111N1
Enrollment
140
Registered
2019-10-28
Start date
2014-04-04
Completion date
Unknown
Last updated
2019-11-05

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

Conditions

Osteopenia. Menopausal and other perimenopausal disorders

Interventions

Intervention 1: Intervention group: Treatment with 70 mg weekly Alendronate for 2 years. Intervention 2: Intervention group: Treatment with 35 mg weekly Alendronate for 2 years.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansour Karimifar

Esfahan University of Medical Sciences

karimifar@med.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

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