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MK0217, /Duration of Treatment : 12 Months

Phase 3

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Organon & Co.|Last Updated: Aug 14, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00389740A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)PHASE3 COMPLETED 400Apr 2, 2001Jan 16, 2003Aug 14, 2024 -
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Study Endpoints
Primary Endpoints
Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary Endpoints
Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0217, /Duration of Treatment : 12 MonthsDRUG -
Comparator : raloxifene hydrochloride /Duration of Treatment : 12 MonthsDRUG -
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Eligibility Criteria
Age Range40 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Patient is postmenopausal (or surgically menopausal) for at least 6 months * Patient must be diagnosed with osteoporosis * Patient has spinal anatomy suitable for DEXA of the lumbar spine Exclusion Criteria: * Patient is receiving or has received treatment prior to randomiza...

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