A proof-of-concept study of SB-751689 in male and female subjects with a fractured distal radius.
- Conditions
- Distal radius fractureMedDRA version: 9.1Level: LLTClassification code 10017076Term: Fracture
- Registration Number
- EUCTR2007-001477-29-CZ
- Lead Sponsor
- GlaxoSmithKline R & D Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 219
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: Unilateral, 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]
• Multiple fractures of bones, other than the limb with the distal radius fracture,
are permissible if the subject can perform the protocol-required procedures.
3. Fracture treatment: Received conservative treatment of the distal radius fracture,
including closed reduction and immobilization device (such as cast, splint, or brace)
4. Study participants: Ambulatory male and female subjects aged =35 to <80 years of age who have sustained a closed, unilateral, fracture of the distal radius no more than 5 days prior to randomization.
Females of non child-bearing potential defined as: >1 year postmenopausal, which
can be >1 year of spontaneous amenorrhea or >1 year post surgical bilateral
oophorectomy. Use follicle stimulating hormone [FSH] levels >40mIU/mL to
confirm surgical postmenopausal status, where bilateral oophorectomy status is
uncertain.
Females of child-bearing potential must have a negative urine ßhCG pregnancy test at the Screening visit and agree to practice acceptable 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
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 - all additional fractures in the limb (including hand and humerus) with the distal radial fracture are excluded, any fracture of the contralateral upper or lower arm, wrist or hand that would interfere with obtaining measurements on the dynamometer are excluded, pathological (tumor-related) fractures, 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 <0.1 or >10.0 mIU/L, no exclusion if in the range 0.1-4.5 mIU/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 corrected 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
Concomitant therapy with proton pump inhibitors, daily chronic use of histamine -2 receptor antagonists, antacids administered within 2 hours of study medication
Women who are pregnant or breast-feeding are not allowed in the study. Females of child-bearing potential must have a negative urine ßhCG pregnancy test at the Screening and Randomization visit and agree to practice acceptable highly effective methods of birth control through the duration of the study and for 4 weeks following the last dose of study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method