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Testosterone

Phase 3

Hip Fracture | Small molecule | Musculoskeletal |Harvard Bioscience, Inc.|Last Updated: Feb 4, 2025

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02938923Starting a Testosterone and Exercise Program After Hip InjuryPHASE3 COMPLETED 129Mar 5, 2019Nov 6, 2023Feb 4, 20258 United States
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Study Endpoints
Primary Endpoints
Change in Six Minute Walk Distance
Baseline to 6 months

Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.

Secondary Endpoints
Change in Total Lean Body Mass
Baseline to 6 months
Change in Appendicular Lean Body Mass
Baseline to 6 months
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Baseline to 6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Exercise + Testosterone (EX + T)EXPERIMENTALSupervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration.
Exercise + Placebo (EX + P)PLACEBO_COMPARATORSupervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Enhanced Usual Care (EUC)OTHERHome exercise program 3 times per week and monthly health education modules, both for six months duration.
Interventions
NameTypeDescription
TestosteroneDRUGTopical testosterone gel 1%
Placebo gelDRUGInactive skin gel
Supervised exercise trainingBEHAVIORALMulticomponent exercise program focused primarily on progressive resistance exercise training
Home exercise programBEHAVIORALFlexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education ModulesBEHAVIORAL30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
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Eligibility Criteria
Age Range65 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Female 65 years and older. * Surgical repair of a non-pathologic fracture of the proximal femur (Including: femoral neck or intracapsular, intertrochanteric, and subtrochanteric fractures) with a surgical repair date that is within 24 weeks at randomization. If a revision of s...

Countries:United States
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Competitive Landscape -Fractures 35 trials