Colles' Fracture
Conditions
Brief summary
Effects of Teriparatide on Distal Radius Fracture Healing
Interventions
DRUGTeriparatide
DRUGplacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Ambulatory, postmenopausal, women 45 to 85 years of age. Postmenopausal is defined as at least 2 years without regular menses Sustained a unilateral, dorsally angulated fracture of the distal radius within 10 days Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, or brace) Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator 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. In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily, is able to satisfactorily use a pen-type injection delivery system, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector
Exclusion criteria
Increased baseline risk of osteosarcoma 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 definitely treated Have currently known, suspected, or history of other diseases that affect bone metabolism other than postmenopausal osteoporosis or cause secondary osteoporosis that has been clinically active in the 1 year prior to visit 2 Have elevated serum calcium values Active liver disease or clinical jaundice History of symptomatic nephro-or urolithiasis in the 2 years prior to visit 2 Previous fractures or bone surgery in the currently fractured distal forearm Joint disease such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm Requirement for chronic treatment with nonsteroidal anti-inflammatory drugs defined as more than 3 consecutive months of any NSAID treatment Treatment with: Oral bisphosphonates for more than 18 months during the prior 3 years, or have received any oral or intravenous biphosphonate therapy within the last 2 months prior to screening. Oral strontium ranelate for any duration Systemic corticosteroids 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, oric, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions. Fluoride at therapeutic doses (greater than or equal to 20mg/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to radiographic healing | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcomes for this trial | — |
Countries
Mexico, Poland, Romania, Sweden, United States
Outcome results
None listed