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This study aims to prove non-inferiority of the efficacy of Masibone S (alendronate sodium trihydrate 70mg, oral solution) on the treatment of postmenopausal osteoporosis compared to the efficacy of Fosamax (alendronate sodium 70mg, oral tablet). The effect of Masibone S and Fosamax on bone mineral density in postmenopausal women with osteoporosis will be compared and analyzed. This study included a total 170 patients (85 per subgroup) for multi-center, randomized, open-label, parallel clinical trial. The drugs will be maintained for a total of 48 weeks. The primary endpoint is the difference of bone mineral density change at lumbar spine measured by DEXA between two groups.
Enrollment
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Volunteers
Inclusion criteria
postmenopausal women ≥50 years old
osteoporosis - BMD T-score ≤-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks
Those who voluntarily agree in written form to participate in the clinical trial after hearing the explanation of this clinical trial and those who do not have any of exclusion criteria
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170 participants in 2 patient groups
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Central trial contact
Yumie Rhee
Data sourced from clinicaltrials.gov
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