Osteoporosis
Conditions
Brief summary
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.
Interventions
DRUGMasibone S
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.
DRUGFosamax
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. postmenopausal women ≥50 years old 2. 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% 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of bone mineral density at lumbar spine | 48 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum levels of bone turnover markers | 24 and 48 weeks | 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. |
| Adherence to drug | 24 and 48 weeks | The proportion of patients who compliantly uses drugs after 24 and 48 weeks of intervention will be evaluated. |
Countries
South Korea
Contacts
Primary ContactYumie Rhee
Outcome results
None listed