A proof-of-concept study of SB-751689 in men and post-menopausal women with a fractured distal radius.

Conditions: Distal radius fracture
MedDRA version: 9.1Level: LLTClassification code 10017076Term: Fracture

Registration Number: EUCTR2007-001477-29-NL

Lead Sponsor: GlaxoSmithKline R & D Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 219

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 < 80years of age OR ambulatory
post menopausal females who have sustained a closed, unilateral, fracture of the distal radius no more than 5 days prior to randomisation
Post menopausal defined as: female aged = 35 but < 80 years at screening and
>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. Note: Results of screening laboratory samples must be available for review prior to randomisation to determine eligibility
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

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 <0.1 or >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