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MK-217A/Alendronate 70-mg/Vitamin D3 Combination

Phase 3

Osteoporosis | Small molecule | Endocrine |Organon & Co.|Last Updated: Apr 22, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

MK-217A/Alendronate 70-mg/Vitamin D3 Combination · 1 trial · 1 indication

Phase 3 1
NCT01437111Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)Osteoporosis
COMPLETED200 Analytics
PHASE3COMPLETED
Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
Week 26

Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.

Secondary Endpoints

Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
Baseline and Week 26
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fosamax PlusEXPERIMENTALCalcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants

Interventions

NameTypeDescription
MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination TabletDRUGOne combination tablet orally once a week
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

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: ...

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Competitive Landscape -Osteoporosis 8 trials