Phase 4
Completed N=13
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Osteoporosis · Atypical Femoral Fracture
Source: ClinicalTrials.gov NCT01705587 ↗
Enrolled (actual)
13
Serious AEs
38.5%
Results posted
Dec 2017
Primary outcomePrimary: Radiologic Evidence of Bone Healing — 12.6; 11.2; 15.4; 13.2 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiologic Evidence of Bone Healing |
12.6; 11.2; 15.4; 13.2 | — |
| PRIMARY Radiologic Evidence of Healing |
5; 4 | — |
| SECONDARY Radiologic Healing |
— | — |
| SECONDARY Increased Bone Density |
2.1; -0.6; 2.8; 5.4; -1.6; -0.8 | — |
| SECONDARY Quality of Life Improvements |
49.3; 65.0; 48.2; 68.8; 75.0; 72.9 | — |
| SECONDARY Difference in Biochemical Markers of Bone Turnover |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01705587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.