Effects of Teriparatide on Distal Radius Fracture Healing
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Effects of Teriparatide on Distal Radius Fracture Healing
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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