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rhBMP-2/CPM

Phase 2

Fractures | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Feb 28, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment247

FDA Designations

No designations recorded

Clinical trial landscape

rhBMP-2/CPM · 4 trials · 3 indications

Phase 2 2Phase 1 2
NCT00384852A Study of rhBMP-2/CPM in Closed Fractures of the HumerusFractures
COMPLETED139 Analytics
NCT00384358Feasibility And Safety Study Of rhBMP-2/CPM For Hip FracturesFractures
COMPLETED108 Analytics
PHASE2COMPLETED
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
FracturesUnlock trial analytics
PHASE2COMPLETED
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
FracturesUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy variable in this study is radiographic union.
Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
upon completion 6 months of follow-up
Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
Feasibility measures include
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.

Secondary Endpoints

To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.
6 months follow-up
To estimate the success and failure rates associated with key fracture outcomes.
6 months follow-up
Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL1.0 mg/mL rhBMP-2/CPM + SOC
BEXPERIMENTAL2.0 mg/mL rhBMP-2/CPM + SOC
CACTIVE_COMPARATORBuffer/CPM + SOC
DOTHERStandard of Care Alone (SOC)

Interventions

NameTypeDescription
rhBMP-2/CPMDRUG -
surgical intervention aloneOTHERsurgical internal fixation of fracture defines the standard of care group
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Skeletally mature subjects age 18 years or older. * Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture. * Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury. Exclusion Criteria: * Shoul...

Countries:United StatesAustraliaBrazilCanadaFinlandFranceGermanyMexicoNorwayRomaniaSwedenHungaryUnited Kingdom
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Competitive Landscape -Fractures 35 trials

Frequently asked questions about rhBMP-2/CPM

What is rhBMP-2/CPM used for?

rhBMP-2/CPM is an investigational small molecule being developed for musculoskeletal conditions, including osteoarthritis, radius fractures, and other fractures. It has been studied in clinical trials for closed distal radius fractures, open wedge osteotomies, hip fractures, and closed fractures of the humerus.

Who is developing rhBMP-2/CPM?

Pfizer, Inc. (NYSE: PFE) is developing rhBMP-2/CPM. The drug is currently in Phase 2 clinical development for musculoskeletal indications.

What phase is rhBMP-2/CPM in?

rhBMP-2/CPM is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, along with two earlier-phase studies.

What clinical trials has rhBMP-2/CPM been in?

rhBMP-2/CPM has been studied in four completed trials. NCT00161629 evaluated it in closed distal radius fractures, NCT00243295 in open wedge osteotomies, NCT00384358 in hip fractures, and NCT00384852 in closed fractures of the humerus. Total enrollment across these studies was 247 participants.

Is rhBMP-2/CPM the same as rhMBP-2/CPM?

rhBMP-2/CPM is the drug name used in most trials. One trial, NCT00243295, refers to the drug as rhMBP-2/CPM, which appears to be a typographical variant of the same compound. Both names refer to the same investigational therapy.