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

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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

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Atypical Femoral Fracture Drug: teriparatide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Study Start Date : December 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Immediate teriparatide
Open label teriparatide given immediately following surgical repair of fracture
Drug: teriparatide
20 microgram once-daily subcutaneous injection
Other Name: Forteo

Experimental: Delayed teriparatide
Open label teriparatide given six months following surgical repair of fracture
Drug: teriparatide
20 microgram once-daily subcutaneous injection
Other Name: Forteo




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Radiologic Healing [ Time Frame: at 2, 6, 24, and 48 weeks ]
  2. 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

  3. 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.

  4. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705587


Locations
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United States, Pennsylvania
University of Pittsburgh, Osteoporosis Prevention & Treatment Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Susan L. Greenspan
University of Pittsburgh
Eli Lilly and Company
Investigators
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Principal Investigator: Susan L. Greenspan, MD University of Pittsburgh

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Responsible Party: Susan L. Greenspan, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01705587     History of Changes
Other Study ID Numbers: PRO12040560 (FiX-IT)
First Posted: October 12, 2012    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Keywords provided by Susan L. Greenspan, University of Pittsburgh:
osteoporosis
atypical femoral fractures
prior bisphosphonate treatment
postmenopausal women
bone loss
Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Leg Injuries
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents