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Alendronate

Phase 3

Postmenopausal 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,053
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092014A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)PHASE3 COMPLETED 1,053 — — Sep 1, 2002Apr 1, 2004Aug 14, 2024 - —
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Study Endpoints
Primary Endpoints
Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months
Baseline and 12 months
Mean percent change from baseline in hip trochanter BMD at 24 months
Baseline and 24 months
Secondary Endpoints
Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months
Baseline and 12 months
Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months
Baseline and 24 months
Change from baseline in biochemical markers of bone turnover at 12 months
Baseline and 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Alendronate 70 mgEXPERIMENTALAlendronate sodium, 70 mg, orally once weekly for up to 24 months
Risendronate 35 mgACTIVE_COMPARATORRisendronate, 35 mg, orally once weekly for up to 24 months
Interventions
NameTypeDescription
AlendronateDRUGAlendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
Risedronate 35 mgDRUGRisendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
Elemental CalciumDIETARY_SUPPLEMENTElemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
Vitamin DDIETARY_SUPPLEMENTVitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
Risendronate placeboDRUGRisendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
Alendronate placeboDRUGAlendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
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Eligibility Criteria
Age Range25 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Women with postmenopausal osteoporosis Exclusion Criteria: * Bilateral hip replacements * Esophageal abnormalities * Metabolic bone disease (example - Vitamin D deficiency) * Medications that would affect the breakdown or build-up of bone turnover

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