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MK0217/Duration of Treatment : 12 Months

Phase 3

Osteoporosis | 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment173
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00480766A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)PHASE3 COMPLETED 173Jul 1, 2001Aug 1, 2003Aug 14, 2024 -
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Study Endpoints
Primary Endpoints
Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo
Secondary Endpoints
Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0217/Duration of Treatment : 12 MonthsDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture Exclusion Criteria: * Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease...

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Competitive Landscape -Osteoporosis 8 trials