Recent Updates
Recently added Catalysts

ibandronate

Phase 3

Postmenopausal Osteoporosis | Small molecule | Endocrine |Organon & Co.|Last Updated: Feb 2, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment203
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092053Study of Investigational Drug in Osteoporosis (MK-0217-908)PHASE3 COMPLETED 203Dec 1, 2004Jul 1, 2005Feb 2, 2022 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in serum levels of CTX-I (log-transformed fraction) from Week 9 to Week 12
Baseline, Week 9, Week 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants will receive 3 placebo tablets once a month, for 3 months, on the first day of each treatment cycle.
ibandronate 100 mgEXPERIMENTALParticipants will receive 2 ibandronate 50 mg tablets and 1 placebo tablet once a month, for 3 months, on the first day of each treatment cycle.
ibandronate 150 mgEXPERIMENTALParticipants will receive 3 ibandronate 50 mg tablets once a month, for 3 months, on the first day of each treatment cycle.
Interventions
NameTypeDescription
PlaceboDRUGtablets
ibandronateDRUG50 mg tablets
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: \[BMD \> 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by eac...

Unlock Eligibility Criteria