A proof-of-concept study of SB-751689 in male and female with a fractured distal radius.
- Conditions
- distal radius fracture10005959
- Registration Number
- NL-OMON31582
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
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.
3. Fracture treatment: Received conservative treatment of the distal radius fracture, including closed reduction and immobilization device
4. Men or Women: Ambulatory males or females 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.
5. Protocol compliance
1. Timing of fracture: Any treatment of a fractured distal radius that occurred more than 5 days after the fracture sustaining injury
2. Fracture: All B- and C-type fractures (intra-articular) according to AO Fracture classification that would likely require open reduction and internal fixation
3. Prior fractures: Prior fracture of the same wrist as an adult
6. Bone metabolism: History or concurrent diseases affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism, etc.)
7. Skeleton: History of skeletal immaturity or pathologic (tumor-related) fracture
8. Arthritis
9 Thyroid hormone replacement, Subjects will be excluded if TSH levels are <0.1 or >10.0 mIU/L. If TSH is >4.5 to <10.0 mIU/mL, measure T4 and exclude the subject only if the T4 is outside the normal range
12. Malignancy: Malignant disease diagnosed within the previous 5 years or active peptic ulcer disease
14. Liver disease
15. Drug or alcohol abuse: Drug or alcohol abuse (past or current) within the previous 12 months
18. Surgical and medical conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective<br /><br>To evaluate the effects of SB-751689 on the time to radiographic healing,<br /><br>defined as the interval in days between the occurrence of the radial fracture<br /><br>and the time of complete bridging and/or disappearance of fracture line at 3 of<br /><br>the following 4 cortices: dorsal, volar, radial, or ulnar.</p><br>
- Secondary Outcome Measures
Name Time Method