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Risedronate

Phase 3

Osteoporosis | Small molecule | Endocrine |Bone Biologics Corp|Last Updated: Mar 4, 2014

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical trial landscape

Risedronate · 1 trial · 1 indication

Phase 3 1
NCT01611571Combination Risedronate - Parathyroid Hormone Trial in Male OsteoporosisOsteoporosis
COMPLETED31 Analytics
PHASE3COMPLETED
Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
OsteoporosisUnlock trial analytics
Study Endpoints
Primary Endpoints
Change in Spine Bone Density
18 months

change in spine bone density at 18 months measured by DXA 18 and 24 months

Secondary Endpoints
Change in Hip Bone Density
baseline and 18 months
Change in Forearm Bone Density
baseline and 18 months
New Morphometric Vertebral Fractures
baseline through 18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active Risedronate Placebo TeriparatideACTIVE_COMPARATORActive Risedronate + Placebo Teriparatide for 18 months / Active Risedronate for 6 months
Active Risedronate Active TeriparatideACTIVE_COMPARATORActive Risedronate + Active Teriparatide for 18 months / Active Risedronate for 6 months
Placebo Risedronate Active TeriparatideACTIVE_COMPARATORPlacebo Risedronate Active Teriparatide for 18 months / Active Risedronate for 6 months
Interventions
NameTypeDescription
RisedronateDRUGweekly risedronate
TeriparatideDRUGdaily teriparatide
Placebo TeriparatideDRUGdaily placebo of teriparatide
placebo RisedronateDRUGweekly placebo of Risedronic Acid
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Eligibility Criteria
Age Range30 Years to 85 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males, ages 30-85 with osteoporosis. 2. Osteoporosis can be due to hypogonadism, past steroid use, or idiopathic. 3. Patients with hypogonadism can be included if their replacement dosage of testosterone has been stable for at least 18 months. 4. Bone mineral density must be ...

Countries:United States
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Competitive Landscape -Osteoporosis 8 trials