Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborators:
University of Pittsburgh
Eli Lilly and Company
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 9, 2012
First Posted Date  ICMJE October 12, 2012
Results First Submitted Date  ICMJE August 30, 2017
Results First Posted Date  ICMJE December 12, 2017
Last Update Posted Date December 12, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Atypical Femoral Fracture
Intervention  ICMJE Drug: teriparatide
20 microgram once-daily subcutaneous injection
Other Name: Forteo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2017)
13
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2012)
24
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01705587
Other Study ID Numbers  ICMJE PRO12040560 (FiX-IT)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan L. Greenspan, University of Pittsburgh
Study Sponsor  ICMJE Susan L. Greenspan
Collaborators  ICMJE
  • University of Pittsburgh
  • Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Susan L. Greenspan, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP