Distal radius fracture MedDRA version: 9.1 Level: LLT Classification code 10017076 Term: Fracture
Conditions
Interventions
Product Code: SB-751689-A
Pharmaceutical Form: Tablet
CAS Number: 702686-96-2
Current Sponsor code: SB-751689
Other descriptive name: Ronacaleret hydrochloride
Concentration unit: mg milligram(s)
Conc
Sponsors
GlaxoSmithKline R & D Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Informed Consent: Subject is willing and able to provide written informed consent 2. Fracture type: Extra-articular distal radius fractures AO/ASIF types 23-A2 and 23-A3 are permissible. (Arbeitsgemeinschaft für Osteosynthesefragen (AO)/ Association for the Study of Internal Fixation (ASIF)) 3. Fracture treatment: Received conservative treatment of the distal radius fracture, including closed reduction and immobilization device (such as cast, splint, or brace) 4. Men or Women: Ambulatory males aged =35 to 1 year post-menopausal, which can be >1 year of spontaneous amenorrhea or > 1 year post surgical bilateral oophorectomy. Use follicle stimulating hormone [FSH] levels >40 mIU/mL to confirm surgical post-menopausal status, where bilateral oophorectomy status is uncertain. Females of child bearing potential must have a negative beta hCG pregnancy test at the screening visit and agree to practice acceptably highly effective methods of birth control throughout the duration of the study. Highly effective birth control methods include those preventative measures taken to avoid pregnancy that have a failure rate of less than 1% per year. 5. Protocol compliance: Subject who, in the opinion of the investigator, is willing and able to comply with the requirements of the protocol, including ability to understand patient reported outcomes (PRO) questionnaires 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any treatment of a fracture that occurred more than 5 days after the fracture sustaining injury, all B- and C-type fractures that would likely require open reduction and internal fixation, prior fracture of the same wrist as an adult, placement of hardware (pins or plates) History/current conditions: synovial pseudoarthrosis, congenital pseudoarthrosis, or active osteomyelitis, diseases affecting bone metabolism, skeletal immaturity or pathologic fracture, arthritis - active disease or inflammatory joint disease, TSH 10.0 IU/L, nephrolithiasis, increased risk of osteosarcoma, malignant disease, malabsorption syndrome, liver disease or known hepatic or biliary abnormalities, drug or alcohol abuse, risk factors for Torsades de Pointes, marked baseline prolongation of QT/QTc interval, certain surgical/medical conditions (myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, cardiac arrhythmia, congestive heart failure, cardiac pacemaker, or stroke), neurological diseases, biological abnormality (HIV, significant mental illness), inability to swallow, Use of the following medications, some have time restrictions associated with their use : treatment with strontium ranelate or intravenous bisphosphonate, oral bisphosphonate, fluoride, PTH, PTH analogues, chronic systemic steroids, hormones estrogens/"natural estrogen preparations, cyclosporine, tacrolimus, methotrexate, clarithromycin, erythromycin, telithromycin, prior investigational drug usage, vitamin A in excess of 10,000 IU per day, heparin, lithium, anticonvulsant medications, nefazodone, digoxin, NSAIDs, inability to tolerate with calcium or vitamin D, cyclosporine or diltiazem, verapamil, cyclosporine, oral tacrolimus, ritonavir, quinidine, all oral azole antifungal, birth control (strongly recommended), raised serum calcium outside local lab range, raised ALT or AST above 2 fold the upper limit of local lab ref range, GFR<35ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of SB-751689 on the time to radiographic healing, defined as the interval in days between the occurrence of the radial fracture and the time of complete bridging and/or disappearance of fracture line at 3 of the following 4 cortices: dorsal, volar, radial, or ulnar.;Secondary Objective: 1. To evaluate the safety and tolerability of SB-751689 administered for a period of 12 weeks compared with placebo 2. To evaluate the dose regimen- and concentration-response relationships for SB- 751689 on • serum PTH and calcium concentrations • biomarkers of bone turnover: serum cross-linked C-terminal telopeptide 1 chain of type I collagen (CTX), procollagen type 1 N-propeptide (P1NP), bone-specific alkaline phosphatase (BSAP), and osteocalcin (OC) concentration. 3. To evaluate radiographically: • The baseline incidence of radio-ulnar joint involvement and radiocarpal joint involvement • The effects of SB-751689 on anatomical deformity of the wrist 4. To evaluate the effects of SB-751689 on the clinical assessment of healing as defined by presence and/or absence of pain and swelling and range-of-motion, Timing (dates) for cast removal and initiation of physical rehabilitation will also be assessed;Primary end point(s): Time to radiographic fracture healing as defined by the interval in days between the occurence of the fractue and the time of complete bridging and/or disappearance of fracture line at 3 of the 4 cortices (dorsal, volar, radial, ulnar) | — |
Countries
Czech Republic, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed