Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis; Atypical Femoral Fracture
Intervention: teriparatide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Susan L. Greenspan, MD, Principal Investigator, Affiliation: University of Pittsburgh
Overall contact: Karen T. Vujevich, MSN, CRNP, Phone: 412-692-2479, Email: kcook@pitt.edu
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.
Clinical Details
Official title: Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Radiologic evidence of healing
Secondary outcome: Radiologic healingIncreased bone density Quality of Life improvements Difference in biochemical markers of bone turnover
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Karen T. Vujevich, MSN, CRNP, Phone: 412-692-2479, Email: kcook@pitt.edu
University of Pittsburgh, Osteoporosis Prevention & Treatment Center, Pittsburgh, Pennsylvania 15213, United States; Recruiting Karen T. Vujevich, MSN, CRNP, Phone: 412-692-2479, Email: kcook@pitt.edu Gary Gruen, MD, Sub-Investigator Peter Siska, MD, Sub-Investigator Ivan Tarkin, MD, Sub-Investigator Karen T. Vujevich, MSN, CRNP, Sub-Investigator Dana Farrell, BS, Sub-Investigator
Additional Information
Starting date: December 2012
Last updated: June 9, 2015
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