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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masibone S | Experimental | Masibone S (alendronate sodium trihydrate 70mg, oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks |
|
| Fosamax | Active Comparator | Fosamax (aledronate sodium 70mg, oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masibone S | Drug | The investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium trihydrate 70mg (oral solution) 1 bottle weekly and cholecalciferol 1000U/calcium 100mg 1T daily use. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of bone mineral density at lumbar spine | DEXA is used to evaluate the change of bone mineral density at lumbar spine after 48 weeks of drug intervention compared to those at baseline | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum levels of bone turnover markers | Serum levels bone turnover markers (CTX and P1NP) is measured at baseline and after 24 and 48 weeks of drug intervention and the change of serum levels of CTX and P1NP is evaluated. | 24 and 48 weeks |
| Adherence to drug |
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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
- BMD T-score -1.0~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and history of osteoporotic fractures - BMD T-score -1.0~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and FRAX MOF >20% or HF >3%
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
Exclusion Criteria:
postmenopausal women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yumie Rhee | Contact | +82-2-2228-0883 | yumie@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Yumie Rhee | Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39589664 | Derived | Baek S, Ahn SH, Hong N, Seo DH, Hong S, Rhee Y. Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial. Arch Osteoporos. 2024 Nov 26;19(1):119. doi: 10.1007/s11657-024-01480-6. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Fosamax | Drug | The investigators will evaluate the change of bone mineral density at lumbar spine measured by DEXA after 48 weeks of alendronate sodium 70mg (oral tablet) 1T weekly and cholecalciferol 1000U/calcium 100mg 1T daily use. |
|
The proportion of patients who compliantly uses drugs after 24 and 48 weeks of intervention will be evaluated. |
| 24 and 48 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |