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

NCT01705587 | Completed Phase 4 Results

• 1 other identifier: PRO12040560 (FiX-IT)
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Atypical Femoral Fracture

Keywords

osteoporosis; atypical femoral fractures; prior bisphosphonate treatment; postmenopausal women; bone loss

Outcome Measures

Primary Outcomes (2)

• 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.

  6, 12 months of treatment

• Radiologic Evidence of Healing

  Number of participants with persistence of alignment as determined by a radiologist.

  at 10 weeks for immediate teriparatide group

Secondary Outcomes (4)

• Radiologic Healing

  at 2, 6, 24, and 48 weeks

• Increased Bone Density

  at 6 and 12 months

• Quality of Life Improvements

  at 12 months

• Difference in Biochemical Markers of Bone Turnover

  intervals over 12-18 months depending on treatment group

Study Arms (2)

Immediate teriparatide

EXPERIMENTAL

Open label teriparatide given immediately following surgical repair of fracture

Drug: teriparatide

Delayed teriparatide

EXPERIMENTAL

Open label teriparatide given six months following surgical repair of fracture

Drug: teriparatide

Interventions

teriparatide DRUG

20 microgram once-daily subcutaneous injection

Also known as: Forteo

Delayed teriparatide; Immediate teriparatide

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Susan L. Greenspan: lead
• University of Pittsburgh: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Pittsburgh, Osteoporosis Prevention & Treatment Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Susan Greenspan, MD
• Organization: University of Pittsburgh

greenspn@pitt.edu

412-692-2477

Study Officials

• Susan L. Greenspan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Locations

US (1)