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

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