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bisphosphonates, calcium, and vitamin D

Phase 2

Osteoporosis | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Mar 20, 2020

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00752557Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMDPHASE2 COMPLETED 50Dec 3, 2008Apr 24, 2015Mar 20, 202035 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
Baseline, 12 months post dose

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.

Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
At Month 12

Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix \[CPM\]).

Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
At Month 12

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.

Secondary Endpoints
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
24 months
Number Participant Responses to Injectability Questionnaire Injected Population
Participants were monitored after treatment administration (dosing period)
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Baseline up to 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALrhBMP-2/CPM , 1.0 mg/mL
2EXPERIMENTALrhBMP-2/CPM , 2.0 mg/mL
3ACTIVE_COMPARATOROral bisphosphonate therapy (standard of care)
Interventions
NameTypeDescription
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)DRUGSingle, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
bisphosphonates, calcium, and vitamin DDRUGOral bisphosphonate therapy
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Eligibility Criteria
Age Range65 Years — 85 Years
SexFEMALE
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years. * BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the ...

Countries:United StatesBelgiumPolandSpain
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Competitive Landscape -Osteoporosis 8 trials