Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures (NCT01896011) | Clinical Trial Compass
CompletedPhase 3
Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures
Canada34 participantsStarted 2013-07
Plain-language summary
Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often occur without warning, are highly debilitating, and are slow to heal. As physicians learn more about them, AFFs are increasingly being identified prior to a total break. However, there's no evidence on the best way to treat these non-displaced AFFs. One option is teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF patients with an incomplete break will help accelerate fracture healing and prevent surgical intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months and number of participants requiring surgical intervention at 12 months. Investigators will recruit 60 women and men over the age of 30 who have experienced an incomplete AFF. Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial examining the use of Teriparatide in this population is urgently needed.
Who can participate
Age range30 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height;
✓. From distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft.
✓. Radiographic confirmation of AFF features is required for a definitive diagnosis. Incomplete AFF features include cortical thickening, cortical beaking, and lucency line. Patients with cortical beaking without lucency line can be included.
Exclusion criteria
✕. pregnant or nursing mothers, or women who are planning on pregnancy within 1 year of completing teriparatide therapy,
✕. hypersensitivity to teriparatide,
✕. severe renal impairment,
✕. multiple myeloma,
✕. active cancer in past 5 years (other than non-melanoma skin cancer),
✕. primary hyperparathyroidism,
What they're measuring
1
Change in the modified The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)of the affected limb (the femur that has the incomplete AFF)
Timeframe: baseline to 12 months
2
The proportion of patients requiring surgical intervention