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

 -  postmenopausal women

 -  with osteoporosis who have been on bisphosphonate therapy for one year or more (all
 bisphosphonates will be included such as alendronate, risdedronate, ibandronate, or
 zoledronic acid).

 -  Patients will also be included if they are on glucocorticoids or other medications
 known to affect bone mineral metabolism as these are often found in patients with
 these types of fractures.

 -  sustain an atypical subtrochanteric or diaphyseal femoral shaft fracture as defined by
 the the 2010 ASBMR task force. An atypical fracture must include all of the following:
 (1) a location in the femur distal to lesser trochanter; (2) no trauma or minimal
 trauma as a fall; (3) transverse or short oblique configuration; (4) noncomminuted;
 and (5) complete fracture extends through both cortices and may be associated with a
 medial spike; incomplete fractures involve only the lateral cortex. Patients who have
 an incomplete fracture can be included if they fall into the 2010 ASBMR task force
 definition.

 Exclusion Criteria:

 -  men

 -  children

 -  those who have had radiation therapy

 -  Paget's disease

 -  treatment with teriparatide for two year in the past

 -  metastatic bone disease

 -  active cancer

 -  hypercalcemia

 -  hyperparathyroidism

 -  metabolic disease other than osteoporosis