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

• ClinicalTrials.gov Identifier: NCT01705587
• Recruitment Status: Completed
• First Posted: October 12, 2012
• Results First Posted: December 12, 2017
• Last Update Posted: December 12, 2017
• Sponsor: Susan L. Greenspan
• Collaborators: University of Pittsburgh; Eli Lilly and Company
• Information provided by (Responsible Party): Susan L. Greenspan, University of Pittsburgh

Tracking Information

• First Submitted Date: October 9, 2012
• First Posted Date: October 12, 2012
• Results First Submitted Date: August 30, 2017
• Results First Posted Date: December 12, 2017
• Last Update Posted Date: December 12, 2017
• Study Start Date: December 2012
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2017)

• Radiologic Evidence of Bone Healing [ Time Frame: 6, 12 months of treatment ]
  The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
• Radiologic Evidence of Healing [ Time Frame: at 10 weeks for immediate teriparatide group ]
  Number of participants with persistence of alignment as determined by a radiologist.

Original Primary Outcome Measures (submitted: October 11, 2012)

Radiologic Evidence of Healing [ Time Frame: at 10 weeks for immediate teriparatide group ]

Compared to delayed teriparatide group receiving therapy 6 months after fracture

Current Secondary Outcome Measures (submitted: November 6, 2017)

• Radiologic Healing [ Time Frame: at 2, 6, 24, and 48 weeks ]
• Increased Bone Density [ Time Frame: at 6 and 12 months ]
  Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck
• Quality of Life Improvements [ Time Frame: at 12 months ]
  Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
• Difference in Biochemical Markers of Bone Turnover [ Time Frame: intervals over 12-18 months depending on treatment group ]
  upfront therapy group compared to delayed therapy group and no therapy group

Original Secondary Outcome Measures (submitted: October 11, 2012)

• Radiologic Healing [ Time Frame: at 2, 6, 24, and 48 weeks ]
• Increased Bone Density [ Time Frame: at 6 and 12 months ]
  as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, and femoral neck
• Quality of Life Improvements [ Time Frame: at 10 weeks and 6 months ]
  as assessed by quality of life questionnaire
• Difference in Biochemical Markers of Bone Turnover [ Time Frame: intervals over 12-18 months depending on treatment group ]
  upfront therapy group compared to delayed therapy group and no therapy group

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fracture (FX) Improvement With Teriparatide: FiX-IT Study
• Official Title: Fracture (FX) Improvement With Teriparatide: FiX-IT Study
• Brief 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Osteoporosis
• Atypical Femoral Fracture

Intervention

Drug: teriparatide

20 microgram once-daily subcutaneous injection

Other Name: Forteo

Study Arms

• Experimental: Immediate teriparatide
  Open label teriparatide given immediately following surgical repair of fracture
  Intervention: Drug: teriparatide
• Experimental: Delayed teriparatide
  Open label teriparatide given six months following surgical repair of fracture
  Intervention: Drug: teriparatide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2017): 13
• Original Estimated Enrollment (submitted: October 11, 2012): 24
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01705587
• Other Study ID Numbers: PRO12040560 (FiX-IT)
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Susan L. Greenspan, University of Pittsburgh
• Study Sponsor: Susan L. Greenspan

Collaborators

• University of Pittsburgh
• Eli Lilly and Company

Investigators

• Principal Investigator: Susan L. Greenspan, MD; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: November 2017