Fracture of distal radius (Colles’) fracture
Conditions
Interventions
Product Name: Teriparatide
Product Code: LY333334
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcuta
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Most important inclusion criteria: [1]Ambulatory, postmenopausal, women 45 to 80 years of age. Postmenopausal is defined as at least 2 years without regular menses. [2]Sustained a unilateral, dorsally angulated fracture of the distal radius within past one week. [3]Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, brace, or other). [4]Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator. [5] Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study. [6]In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector. 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: Patients will be excluded from the study for any of the 25 exclusion criteria. Most important are: [7] No restrictions on concomitant medications after study endpoint, Visit 11 (Week 17) except for oral strontium renalate and flouride. [8] Increased baseline risk of osteosarcoma; this includes subjects with Paget’s disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. [9] History of a malignant neoplasm in the 5 years prior to Visit 2, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study. [10] Have currently known, suspected, or history of other diseases that: ·affect bone metabolism, other than postmenopausal osteoporosis (such as renal osteodystrophy or osteomalacia). ·cause secondary osteoporosis (such as hyperparathyroidism, hyperthyroidism, sprue, inflammatory bowel disease, or malabsorption syndrome) that has been clinically active in the 1 year prior to Visit 2. [11] Have elevated serum calcium values based on local laboratory reference ranges. [12] Active liver disease (liver enzymes more than three times the upper limit of normal) or clinical jaundice. [13] History of symptomatic nephro- or urolithiasis in the 2 years prior to Visit 2. [14] Previous fractures or bone surgery in the currently fractured distal forearm. [15] Joint diseases such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm. [16] Requirement for chronic treatment with nonsteroidal anti?inflammatory drugs (NSAIDs, including Cox?2 inhibitors), defined as more than 3 consecutive months of any NSAID treatment. Dosages of aspirin for coronary heart disease prophylaxis £500 mg/day is acceptable. Patients may take NSAIDs after study endpoint (Week 17). Short-term use of NSAIDs for pain management is acceptable. [17] Treatment with: ·oral bisphosphonates for more than 2 consecutive months in the last 1 year, or have received any oral or intravenous bisphosphonate therapy within the last 6 months prior to screening. Patients may take bisphosphonates after study endpoint (Week 17). ·oral strontium renalate for any duration. ·systemic corticosteroids (other than for adrenal replacement therapy) for more than 30 days (total) in the 6 months prior to Visit 2, or any systemic corticosteroid dose in the 1 month prior to Visit 2. Ophthalmic, otic, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions. Orally inhaled glucocortocsteriods will not exceed a daily dose of 800 mg of beclomethasone. Patients may take systemic corticosteriods after study endpoint (Week 17). ·fluoride at therapeutic doses (³20 mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to Visit 2 (previous or current use of fluoridated water or topical dental fluoride treatment is permitted). ·androgen or other anabolic steroids more recently than 6 months prior to Visit 2. Patients may take androgens or other anabolic steriods after study endpoint (Week 17). [18] History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator. [19]Poor medical or psychiatric con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the effect of 8 weeks of subcutaneous treatment with teriparatide 20 or 40 µg/day versus placebo on time to radiographic fracture healing, (defined by cortical bridging) in postmenopausal women with a unilateral, dorsally angulated, distal radius (Colles’) fracture.;Secondary Objective: Radiologic: ·Time to early endosteal as well as partial endosteal healing as evidenced by radiographs and computed tomography (CT scan) ·Time to trabecular union as evidenced by radiographs and CT scan ·Time to cortical bridging as evidenced by CT scan ·Evaluation of anatomical deformity as evidenced by radiographs. Functional/Clinical: ·Assessment of pain and hand function via the self administered Patient Rated Wrist Evaluation (PRWE). Assessment of disability of the arm, shoulder, and hand via the self?administered Disabilities of the Arm, Shoulder, and Hand (DASH) outcome measure. ·Assessment of grip strength via a JAMAR dynamometer. ·Assessment of wrist Range of Motion (ROM). ·A Mayo wrist score calculated from other functional assessments. Safety:Assessment of vital signs, clinical laboratory tests, and reports of adverse events.;Primary end point(s): Primary end point is the time to a radiographically healed fracture. This is defined as the interval, in days, between the occurrence of the fracture and the time when bridging of the four cortices is determined by x-ray film. | — |
Countries
Spain, Sweden
Outcome results
None listed