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

Primary Purpose

Osteoporosis, Atypical Femoral Fracture

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
teriparatide
Sponsored by
Susan L. Greenspan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, atypical femoral fractures, prior bisphosphonate treatment, postmenopausal women, bone loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh, Osteoporosis Prevention & Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate teriparatide

Delayed teriparatide

Arm Description

Open label teriparatide given immediately following surgical repair of fracture

Open label teriparatide given six months following surgical repair of fracture

Outcomes

Primary Outcome Measures

Radiologic Evidence of Bone Healing
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
Number of participants with persistence of alignment as determined by a radiologist.

Secondary Outcome Measures

Radiologic Healing
Increased Bone Density
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
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
upfront therapy group compared to delayed therapy group and no therapy group

Full Information

First Posted
October 9, 2012
Last Updated
November 6, 2017
Sponsor
Susan L. Greenspan
Collaborators
University of Pittsburgh, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01705587
Brief Title
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Acronym
FiX-IT
Official Title
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan L. Greenspan
Collaborators
University of Pittsburgh, Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Atypical Femoral Fracture
Keywords
osteoporosis, atypical femoral fractures, prior bisphosphonate treatment, postmenopausal women, bone loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate teriparatide
Arm Type
Experimental
Arm Description
Open label teriparatide given immediately following surgical repair of fracture
Arm Title
Delayed teriparatide
Arm Type
Experimental
Arm Description
Open label teriparatide given six months following surgical repair of fracture
Intervention Type
Drug
Intervention Name(s)
teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
20 microgram once-daily subcutaneous injection
Primary Outcome Measure Information:
Title
Radiologic Evidence of Bone Healing
Description
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.
Time Frame
6, 12 months of treatment
Title
Radiologic Evidence of Healing
Description
Number of participants with persistence of alignment as determined by a radiologist.
Time Frame
at 10 weeks for immediate teriparatide group
Secondary Outcome Measure Information:
Title
Radiologic Healing
Time Frame
at 2, 6, 24, and 48 weeks
Title
Increased Bone Density
Description
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
Time Frame
at 6 and 12 months
Title
Quality of Life Improvements
Description
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.
Time Frame
at 12 months
Title
Difference in Biochemical Markers of Bone Turnover
Description
upfront therapy group compared to delayed therapy group and no therapy group
Time Frame
intervals over 12-18 months depending on treatment group

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L. Greenspan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Osteoporosis Prevention & Treatment Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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

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