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MK-217A/Alendronate 70-mg/Vitamin D3 Combination · 1 trial · 1 indication
Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.
| Arm | Type | Description |
|---|---|---|
| Fosamax Plus | EXPERIMENTAL | Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants |
| Name | Type | Description |
|---|---|---|
| MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet | DRUG | One combination tablet orally once a week |
Inclusion Criteria: * Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year * Meets bone mineral density (BMD) criteria * Agree to discontinue any osteoporosis drug treatment for duration of study Exclusion Criteria: ...
MK-217A/Alendronate 70-mg/Vitamin D3 Combination is an investigational small molecule combination tablet being developed for osteoporosis. It pairs alendronate sodium 70 mg with vitamin D3 5600 IU in a single tablet. It is also known as MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet. Organon & Co. (ticker OGN) is the developer.
MK-217A/Alendronate 70-mg/Vitamin D3 Combination is being studied for the treatment of osteoporosis. The single Phase 3 trial in this program enrolled participants with osteoporosis who were 50 years of age or older, and it was open to all sexes. The drug remains investigational for this indication.
Organon & Co., which trades under the ticker OGN, is the developer of MK-217A/Alendronate 70-mg/Vitamin D3 Combination. The company is studying the fixed-dose alendronate and vitamin D3 tablet in osteoporosis. No other developer is associated with this asset in the available program information.
MK-217A/Alendronate 70-mg/Vitamin D3 Combination is in Phase 3 development. The program's single Phase 3 trial, NCT01437111, has completed, and no trials are currently active. The drug is investigational and has not been approved for marketing based on the information available for this program.
MK-217A/Alendronate 70-mg/Vitamin D3 Combination has been studied in one Phase 3 trial, NCT01437111, titled Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329). That trial is completed and enrolled 200 participants with osteoporosis. It was an uncontrolled study without randomization or double blinding.