Phase 1/2Not yet recruiting

PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)

Sponsor
University of Calgary (Academic or other)
Enrolment
54 planned
Conditions
Lower Extremity Fractures; Pelvis; Acetabulum
Interventions
subcutaneous Teriparatide injection
Ages
adults, older adults
Registry
NCT06303284

From the registry

Fragility fractures are common in older adults with weakened bone. At least 1 in 3 females and 1 in 5 males will sustain a fragility fracture in their lifetime, and over 80% of fractures in Canadians aged 50 years and older are attributable to osteoporosis. Fractures of the pelvis, acetabulum and lower extremity in this population are associated with delayed healing, loss of reduction, implant failure and the need for secondary surgery. Reported complication rates range from 21.5% to 40%. Efforts to improve outcomes have focused on surgical fixation technique; there is currently no pharmacological treatment given to promote healing of the fracture itself. Teriparatide is a recombinant form of parathyroid hormone (1-34) that stimulates new bone formation. It is authorized in Canada for the treatment of severe osteoporosis. Its use to promote acute fracture healing is investigational and is not an approved indication. Pre-clinical studies have demonstrated enhanced fracture callus formation and improved mechanical strength of healing bone. Clinical evidence in acute fracture healing…

Primary outcomes

  • Participant recruitment rate
Full record on ClinicalTrials.gov