Distal radius fracture. MedDRA version: 20.0 Level: PT Classification code 10048049 Term: Wrist fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Osteogrow
Pharmaceutical Form: Powder and solvent for implantation paste
INN or Proposed INN: not yet available
Current Sponsor code: rhBMP6
Other descriptive name: RECOMBINANT HUMAN BON
Sponsors
Genera Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting ALL of the following criteria at screening will be eligible for participation in the study: 1.Willing and able to provide informed consent. A signed informed consent form must be provided before any study assessments are done. Patients must be fluent in the language that is spoken by the investigator and the trial staff and in which the informed consent is written. 2.Male or female, age =18 years. 3.Current diagnosis of unilateral dorsally angulated closed fracture of the distal radius within the past 72 hours needing reduction and stabilization by Kirschner wires, but no open surgery. 4.Otherwise healthy as defined by absence of clinically relevant abnormalities identified by a detailed medical history, full physical examination (including vital signs), 12-lead ECG, and clinical laboratory tests. 5.Willing and able to be confined to the hospital/inpatient unit for at least 48h postoperatively and to comply with all other follow-up procedures according to protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Patients meeting ANY of the following criteria at screening will NOT be eligible for participation in the study: 1.Previous fracture or bone surgery in the currently fractured distal forearm. 2.Joint diseases that affect the function of the wrist and/or hand of the injured arm. 3.Previous treatment with bone morphogenic proteins (e.g. Ossigraft). 4.Evidence or history of clinically significant hepatic disease (>3 x ULN for AST/ALT and total bilirubin) or other abnormalities in screening laboratory tests, which in the judgment of the investigator, would interfere with the patient’s participation in the study. 5.Presence or history of an uncontrolled, unstable, clinically significant medical condition (renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease or malignancy) that in the judgment of the investigator may interfere with the interpretation of safety and PK evaluations. 6.Other clinically significant systemic or bone metabolic disease 7.History of symptomatic nephro- or urolithiasis within two years. 8.History of diabetes mellitus. 9.Treatment with an investigational drug within 6 months or 5 half-lives (whichever is longer) preceding the first dose of study medication. 10.Screening 12-lead ECG demonstrating at least 1 of the following: Heart rate >100 bpm, QRS >120 msec, QTc > 430 msec (males), QTc >450 msec (females), or PR interval >220 msec. 11.Breastfeeding a child or planning to become pregnant within 6 months. 12.Use of corticosteroids within 7 days prior to surgery and postoperative for the duration of the study. 13.Known serological evidence of human immunodeficiency virus (HIV) antibody. 14.History of hepatitis B infection within the past year or history of inadequately treated hepatitis C infection. 15.Known drug or alcohol abuse. 16.Donation of blood in excess of 500 mL within 56 days prior to and 1 month following surgery. 17.Current participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Evaluate safety and tolerability of a single dose of Osteogrow delivered locally to the closed distal radius fracture site •Evaluate systemic pharmacokinetics (PK) of rhBMP6 after single dose of Osteogrow delivered locally to the distal radius fracture site •Explore efficacy of a single dose of Osteogrow delivered locally to the distal radius fracture site in acceleration of bone healing ;Secondary Objective: •Explore relationship between systemic PK and systemic safety/tolerability;Primary end point(s): 1) Safety outcomes Safety will be assessed continuously throughout the trial (see Study Schedule) based on clinical signs, serial vital signs assessments, laboratory assessments and spontaneously reported adverse events. Local safety/tolerability will be specifically assessed by clinical inspection (e.g., signs of inflammation), pain and functional assessment and radiological assessment with a particular focus on possible soft tissue ossification. Potential antibody formation and dynamics will be evaluated. 2) PK outcomes Plasma samples will be assayed using a validated assay system for total rhBMP6 within 1 hour before application (time 0) and then at 15, 30, 45, 60 min and 1.5, 2, 4, 6, 12 and 24 hours post-dose. Urine will be collected cumulatively over the first 24 hours post-dose. Concentrations will be used to calculate PK parameters. 3) Efficacy outcomes The efficacy outcome is proportion of “treatment successes”. However, considering the nature of the bone-healing process in the distal radius, definition of a “success” differs in early and late stages. At week 5, a “success” is defined as a presence of a substantial callus which is further defined as “callus index” >1.2 (Eastaugh-Waring 2009). At week 9, a “success” is defined as cortical bridging in 3 out of 4 cortices (Aspenberg 2010a). ;Timepoint(s) of evaluation of this end point: 1) Safety Timepoints Safety will be evaluated throughout the study. 2) Pk Timepoints Plasma samples will be | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): At 9 weeks, cortical healing will be assessed and a subject will be considered a “treatment success” if 3 out 4 cortices achieve bridging. ;Timepoint(s) of evaluation of this end point: After 9 weeks | — |
Countries
Bosnia and Herzegovina, Croatia
Contacts
Public ContactClinical Trials Information
Smart Medico d.o.o.
Outcome results
None listed