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ONO-5334

Phase 2

Osteoporosis | Small molecule | Endocrine |BrainsWay Ltd.|Last Updated: Jun 13, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment285

FDA Designations

No designations recorded

Clinical trial landscape

ONO-5334 · 1 trial · 2 indications

Phase 2 1
NCT00532337Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or OsteoporosisOsteoporosis
COMPLETED285 Analytics
PHASE2COMPLETED
Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
Osteoporosis
NCT00532337285
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Study Endpoints

Primary Endpoints

Mean bone mineral density of the lumbar spine (L 1-4 BMD)
12 months

Secondary Endpoints

Bone mineral density at hip, Biochemical markers of bone turnover
during course of treatment of 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PPLACEBO_COMPARATOR -
E1EXPERIMENTAL -
E2EXPERIMENTAL -
E3EXPERIMENTAL -
AACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ONO-5334DRUGPlacebo - 24/mos.
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Eligibility Criteria

Age Range55 Years to 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1\. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR * Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (...

Countries:Netherlands
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Competitive Landscape -Osteoporosis 8 trials

CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Precision BioSciences, Inc.DTIL1N/AUndisclosed
SI-BONE, Inc.SIBN1 - Undisclosed
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