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Bone Morphogenetic Protein 2

Phase 1

Bone Degenerative Changes | Small molecule | Musculoskeletal |Medtronic plc.|Last Updated: Oct 5, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

Bone Morphogenetic Protein 2 · 1 trial · 3 indications

Phase 1 1
NCT01690260Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow TreatmentBone Degenerative Changes
COMPLETED41 Analytics
PHASE1COMPLETED
Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment
Bone Degenerative ChangesUnlock trial analytics

Study Endpoints

Primary Endpoints

Visible radiological signs of healing after 6 months.
An expected average of 6 months

Radiological signs of healing is a criteria for a successful result. Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in: * Dynamic measurement af immobilization * Ultrasound stimulation * Re-surgery with application of bone graft or bone replacement

Secondary Endpoints

Change in serologic bone markers
An expected average of 6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bone Morphogenetic Protein 2EXPERIMENTALCondition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
Autologous bone graftEXPERIMENTALCondition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.

Interventions

NameTypeDescription
Bone Morphogenetic Protein 2DRUG12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Autologous bone graftPROCEDUREAutologous bone graft in connection with bone docking operation.
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Eligibility Criteria

Age Range20 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Hospitalised for autologous bone graft based on Ilizarow treatment. * Age between 20 and 70 years. Exclusion Criteria: * Rheumatoid osteoarthritis * Malignant disease * Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea) * Pregnancy * Abuse of drugs and al...

Countries:Denmark
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Frequently asked questions about Bone Morphogenetic Protein 2

What is Bone Morphogenetic Protein 2 used for?

Bone Morphogenetic Protein 2 is an investigational small molecule being developed for bone degenerative changes, including osteoarthritis and degenerative disorder of bone. It is intended to address musculoskeletal conditions where bone degeneration occurs. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes Bone Morphogenetic Protein 2?

Bone Morphogenetic Protein 2 is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical research on this investigational drug for bone degenerative changes.

What phase is Bone Morphogenetic Protein 2 in?

Bone Morphogenetic Protein 2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is still in early-stage clinical trials to evaluate its safety and efficacy for bone degenerative changes.

What clinical trials is Bone Morphogenetic Protein 2 in?

Bone Morphogenetic Protein 2 has one completed clinical trial, NCT01690260, titled 'Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment'. This Phase 1 trial enrolled 41 participants in Denmark and was a randomized, double-blind, controlled study. The trial is completed, and no active trials are currently listed.

Is Bone Morphogenetic Protein 2 the same as BMP-2?

Yes, Bone Morphogenetic Protein 2 is commonly referred to as BMP-2. The clinical trial NCT01690260 uses the abbreviation BMP-2 in its title. This alternative name is frequently used in medical literature and clinical research to refer to the same investigational drug.