A Phase 2 interventional study of Teriparatide and placebo in Colles' Fracture, sponsored by Eli Lilly and Company. Completed at 7 sites in 5 countries. Open to female participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-10-12.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
Effects of Teriparatide on Distal Radius Fracture Healing
30 studies on the registry are indexed under Colles' Fracture; 4 are open to participants now.
This study's enrollment of 105 is above the median of 80 across 27 interventional studies indexed under Colles' Fracture.
Browse Colles' Fracture studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Time to radiographic healing
There are no secondary outcomes for this trial
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eli Lilly and Company