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Fracture Recovery for Returning to Duty (Teriparatide STRONG)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533984
Recruitment Status : Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Paul F. Beattie PhD, University of South Carolina

Brief Summary:
FORTEO (teriparatide [rDNA origin]; Eli-Lilly, Indiana, USA) is an injectable synthetic recombinant human parathyroid hormone analog that is commonly used to treat people with osteoporosis. In the current investigation this drug will be tested to evaluate its efficacy to accelerate bone healing and decrease the convalescence time of US Army Basic Trainees who have sustained a diaphyseal tibial stress fracture (DTSF). Investigators from the University of South Carolina will collaborate with military personnel to perform a prospective, randomized, double-blind, placebo-controlled study at Fort Jackson, SC.

Condition or disease Intervention/treatment Phase
Stress Fracture Fracture Healing Military Training Drug: Forteo Injectable Product Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 25, 2023
Estimated Study Completion Date : September 25, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Intervention with 28-day self-injection of Forteo
The active study medication FORTEO is recombinant human parathyroid hormone analog, [rhPTH]. The study medication Forteo (teriparatide [rDNA origin] injection) (Eli-Lilly, Indiana, USA), will be self-administered via a blinded injection pen in the abdominal wall or thigh as described in the product guide. Subjects in the teriparatide arm will receive a 20 mcg dose of the medication daily for 28 days. Following this period the participant will receive standard physical therapy until full-return to duty.
Drug: Forteo Injectable Product
Forteo Injectable Product
Other Name: Standard rehabilitation exercises which are the same for both groups; 500 mg of Calcium PO each day for both groups

Placebo Comparator: Placebo with 28-day self injection of inactive substance
Participants will self-administered a placebo substance normal in a replica, blinded, injection pen via in the abdominal wall or thigh daily for 28 days. Following this period the participant will receive standard physical therapy until full-return to duty.
Other: Placebo
Self-injection of sterile saline




Primary Outcome Measures :
  1. Days from diagnosis to full return to duty [ Time Frame: Spans from time of enrollment until return to full-duty. This could range from 12 weeks to 24 weeks ]
    This will be a time-based measure describing the total number of days of reduced duty associated with the diagnosis of tibial diaphyseal stress fracture. Between-group differences in this measure will be of key importance to determine the functional impact of the study drug compared to placebo.


Secondary Outcome Measures :
  1. Change from baseline in Tibial A-P and Lateral Radiographic Findings [ Time Frame: Follow-up films will be obtained in post-enrollment weeks 4, 12, 16, and 48 ]

    Radiographs will be viewed by study physicians who will make a qualitative, visual estimate of the presence, or absence, of radiographic evidence of disruption of cortical bone in the tibial diaphysis.

    This judgement that will provide an estimate of clinical healing over time.


  2. Change in Non-Contrast Tibial Magnetic Resonance Imaging Findings [ Time Frame: Follow-up images will be obtained in weeks 4, 12, and 48 ]

    Study physicians will use the Fredericson Classification to grade the magnitude of cortical bone and bone marrow involvement in the affected tibial diaphysis. This classification ranges from 0=Normal to 4b= the highest level of stress fracture (linear intra-cortical signal abnormality).

    Classifications using this scale have been demonstrated to have evidence of reliability and validity.

    This measure will provide an estimate of clinical healing over time.


  3. Changes in activity performance measured by the Daily Activity Log [ Time Frame: This will be completed daily between post-enrollment weeks 4-17. It will be completed once in week 48 ]

    This log will be completed daily by the participant to provide an estimate of the likely loading and metabolic expenditure associated with his or her physical activity. 6 items will be sampled and evaluated individually.

    Three items will include distance (miles) from none to greater than 10 miles for marching, marching with combat gear, and running on that given day. The responses from these will be transformed to metabolic equivalent units (METS).

    One item will be categorical listing of the most stressful event of the day.

    The last 2 items will sample pain during activity and pain specific to walking using an 11 item 0-10 numeric rating scale.

    This measure will be used to assess the change in the participant's self report of activity tolerance over time.


  4. Change in the Lower Extremity Functional Scale [ Time Frame: This will be completed weekly during post-enrollment weeks 4-17. It will be completed once in week 48 ]

    The Lower Extremity Functional Scale (LEFS) is a commonly used self-report measure that reflects an individual's ability to perform several specific tasks that may be impaired by lower extremity dysfunction.

    20 items are rated using a 5-point numeric rating scale (0= unable to perform; 4= no difficulty). The highest (best) score = 80% and indicates that the participant reports no difficulty performing activities.

    Measures obtained with the LEFS have strong evidence of reliability and longitudinal construct validity. This measure will be used to assess the change in the participant's self report of activity tolerance over time.


  5. Change in DEXA scan scores [ Time Frame: Post-enrollment week 16. This will be compared to baseline (week 1) images ]

    This measure will be used to generate a T-score that will provide a norm-referenced estimate of overall bone mass of the participant. A T-score of +1.0 to -1.0 would considered normal. -1.0 to - 2.5 would be considered as reduced and classified as osteopenia. A T-score < -2.5 would be considered severely reduced and classified as osteoporosis.

    This measure will used in secondary analysis to sub-classify individuals based upon bone mass at enrollment/inception and will be used to determine changes in overall bone mass upon completion of the study.




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Soldiers actively enlisted in the US Army attached to basic training unit at Fort Jackson who are 18 years of age or older.
  • Soldiers diagnosed with a diaphyseal tibial stress fracture
  • Skeletally mature
  • Willing to self-administer study medication
  • Desire to continue their military commitment and are willing to participate for the length of the project for up to one year.

Exclusion Criteria:

  • History of any form of cancer
  • Currently pregnant
  • Paget's disease of bone
  • Unexplained elevations of alkaline phosphatase (elevations in alkaline phosphatase may signal undiagnosed Paget's disease of bone)
  • Pediatric and young adult participants with open epiphyses
  • Prior external beam or implant radiation therapy involving the skeleton
  • Recent (within the last 6 months) urolithiasis (kidney stones)
  • Elevated serum calcium
  • Elevated uric acid
  • Orthostatic hypotension

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): NCT04533984


Contacts
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Contact: F F Beattie, PhD 803-447-1589 pbeattie@mailbox.sc.edu
Contact: James B Jackson, MD 704-287-3882 Benjamin.Jackson@prismahealth.org

Locations
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United States, South Carolina
Fort Jackson, SC
Columbia, South Carolina, United States, 29207
Contact: Lorri Gibbons, RN    803-315-4655    Lorrigibbons@uscmed.sc.edu   
Contact: Paul F Beattie, PhD    8034471589    pbeattie@mailbox.sc.edu   
Principal Investigator: James B Jackson, MD         
Sponsors and Collaborators
University of South Carolina
Washington University School of Medicine
Investigators
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Principal Investigator: James B Jackson, MD Principal Investigator
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Responsible Party: Paul F. Beattie PhD, Distinguished Clinical Professor Emeritus, Research Affiliate, University of South Carolina
ClinicalTrials.gov Identifier: NCT04533984    
Other Study ID Numbers: Pro00101909
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Paul F. Beattie PhD, University of South Carolina:
Military Training
Stress Fracture
Osteoanabolic
Rehabilitation
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Stress
Wounds and Injuries
Teriparatide
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents