NCT01705587

Fracture (FX) Improvement With Teriparatide: FiX-IT Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Susan L. Greenspan · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.

Detailed description

Up to 24 postmenopausal women with osteoporosis who have been on bisphosphonate therapy for one year or more at any point prior to fracture and have sustained an atypical subtrochanteric or diaphyseal fracture will be enrolled. Subjects randomized to the two intervention arms will self-administer a daily SQ injection of the study medication for 12 months. The primary objective is to demonstrate greater radiologic evidence of healing at 10 weeks in patients on immediate teriparatide compared to those on delayed teriparatide who receive therapy six months after fracture. Secondary end points include (1) radiologic healing at 2, 6, 24, and 46 weeks; (2) increased bone density at 6 and 12 months as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, and femoral neck; (3) quality of life improvements at 10 weeks and 6 months as assessed by quality of life questionnaire and pain score; and (4) differences in biochemical markers of bone turnover in patient with upfront therapy compared to patients with delayed therapy and patients who refuse therapy or for whom teriparatide is contraindicated.

Conditions

• Osteoporosis
• Atypical Femoral Fracture

Interventions

Type	Name	Description
DRUG	teriparatide	20 microgram once-daily subcutaneous injection

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-10-12
• Last updated: 2017-12-12
• Results posted: 2017-12-12

Locations

1 site across 1 country: United States