Stress Fracture Clinical Trial
Official title:
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
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.
GOALS The project goals are to improve combat readiness of U.S. soldiers and sustain the
availability of the military to deploy by, 1) decreasing the number of days not physically
ready for duty after diagnosis of a stress fracture of the tibia, 2) decreasing the need for
a physical profile or medical board after stress fracture of the tibia, and 3) decreasing the
recurrence rates of these injuries.
AIMS AND HYPOTHESES Specific Aim One is to determine the difference in the time from
diagnosis to full return to activity for soldiers with diaphyseal tibia stress fracture who
receive the teriparatide protocol compared to those who receive a placebo-control
self-injection. This aim will be addressed by performing a prospective, longitudinal
randomized, placebo-controlled trial in which 183 soldiers with acutely diagnosed diaphyseal
tibia stress fractures will randomly receive a 1-month course of daily, self-injected 20 mcg.
of teriparatide or daily, self-injected placebo.
- Hypothesis 1.1: Soldiers receiving teriparatide will return to duty 40% more quickly
than those receiving placebo as measured in days from diagnosis to return to duty.
- Hypothesis 1.2: Following return to duty soldiers receiving teriparatide will be able to
sustain a high daily duty load as measured in metabolic equivalents (METs) on a daily
training log.
Specific Aim Two is to determine the long-term effects of the administration of teriparatide.
Study participants will be followed for 1-year after the completion of the study drug year to
determine the incidence of drug related side effects, injury recurrence and/or additional
bone stress injury based on data from the participants' Electronic Medical Record.
- Hypothesis 2.1: Soldiers receiving teriparatide will have a reduced rate of new and/or
recurrent bone stress injuries as measured by their need for a military physical profile
due to bone stress injuries and/or their medical record diagnosis of a bone stress
injury than those treated with placebo.
- Hypothesis 2.2: Soldiers receiving teriparatide will be more likely to complete their
first assigned station as measured by a medical discharge board than those treated with
placebo.
- Hypothesis 2.3: Soldiers receiving teriparatide will have a high bone mass as measured
by DEXA scan age matched t-score than those treated with placebo than those treated with
placebo.
RECRUITMENT AND SCREENING OF PARTICIPANTS Soldiers who have pain in the mid-tibia area while
in basic training at Ft. Jackson, SC report to Moncrief Medical Clinic where they are
medically evaluated by their Primary Care Manager (PCM). The injured soldiers would have
further diagnostic testing in the form of anterior-posterior (A-P) and lateral view
radiographs of the tibia followed by a radio-nucleotide bone scan if indicated. Soldiers
found to have a DTSF report to the physical therapy department for further evaluation and
treatment. The physical therapist will notify the embedded research nurse coordinator of a
new soldier who has a DSTF and will initiate a pre-screen for study participation.
If the DTSF and resulting functional limitation is so severe to require convalescent leave,
the research nurse coordinator will be notified and will approach the patient to provide
general information about the study and invite the patient to learn more about potential
participation. For patients who are interested in participating, the research nurse
coordinator will initiate the informed consent process. All study risks and potential
benefits will be discussed with the patient. Informed consent information and discussion will
include information about the need to self-administer the study medication. Once a fully
executed informed consent document has been signed, the research nurse coordinator will
initiate the study screening visit that will require participants to complete a medical
questionnaire to assess eligibility based on their personal medical history. An initial blood
draw will be obtained that will assess suitability for initiating therapy with teriparatide,
including lab values within the following ranges:
Total serum calcium (normal range 8.5-10.2 mg/dL) Total serum alkaline phosphatase: (normal
range 44 to 147 IU/L) 25-hydroxyvitamin D: (normal range 20 and 40 ng/mL) Parathyroid
Hormone: (normal - 10-65 pig/mL or 10-65 ng/L) Creatinine clearance: (normal 88-128 mL/min
for healthy women or 97-137 mL/min for healthy men) Serum qualitative urine pregnancy test
(females): negative Serum uric acid: (normal 2.4-6.0 mg/dL. (female) and 3.4 - 7.0 mg/dL.
(male). Individuals with laboratory results outside of the normal range will be excluded from
further study procedures and will be ineligible to participate in further study procedures
including being ineligible to be randomized or receive study drug.
To assess bone mass, a bone mineral density (BMD) by dual energy x-ray absorptiometry (DEXA)
of the lumbar spine and bilateral hips will be performed. Additional inclusion and exclusion
criterion are described below. Results from the screening visit will be reviewed by the
medical monitoring team and investigators, who will make the final decision regarding the
patient's eligibility for inclusion in the study.
RANDOMIZATION AND GROUP ASSIGNMENT Upon completion of the screening visit if the consenting
soldier is found eligible for the study, the participant would then be randomized via
computer generated block randomization performed by the research nurse coordinator. There
will be a 1:1 randomization into either the placebo arm or the 20 mcg teriparatide treatment
arm. The Pharmacist of Record would then record which study arm into which the patient was
randomized, dispense the appropriate blinded medication (active study drug vs placebo) to the
research nurse and store the assigned information securely using an encrypted data base. The
injection pens will be blinded to the patient, the research nurse coordinator, and the staff
at Ft. Jackson. If an emergency in patient care arises, any medical staff treating the
patient can request un-blinding by calling the research team. The investigative team will be
immediately informed of any such requests to ensure safety of the study subject.
INTERVENTION Following group assignment, the study participant will have a meeting with the
research nurse to be instructed on care and handling of the medication. The participant will
then directly observe the first administration of the medication to ensure safe and effective
administration and remind the subject/participant to alternate injection sites such as the
abdomen or leg as well as not injecting in same spot on the abdomen or leg each day to avoid
bruising. Next the participant will be a given 28 tablets of 500 mg Calcium to take orally.
The participants will then leave Ft. Jackson and return home for convalescent leave. The
participant will self-administer the mediation daily via injection pen and will receive a
weekly call from the research nurse to ensure study medication compliance and monitor for any
adverse events.
Upon return from 30 days of convalescent leave, participants will report back to Ft. Jackson
and begin the reattachment process to their unit. At this time, the participant will have
another peripheral venous blood draw to evaluate calcium level. Participants will then
transition into the active rehabilitation phase of the study in which they will report daily
to the physical therapy department on Ft. Jackson for treatment, per the standard of care.
During their scheduled reporting at physical therapy, participants will complete a training
log of their previous day's activities. This will allow for a day-to-day tracking of
physiologic load. They will continue to advance the training and activity as tolerated based
on their pain and guidance from the physical therapist until the participant successfully
completes the Army Combat Fitness Test (ACFT) which will qualify them for return to duty.
Once participants have matriculated through basic training, they will receive their initial
duty station. Their military record, including physical profile (limited duty) status, new or
recurrent bone stress injury diagnosis, the need to convene a medical discharge board or
successful uninterrupted completion of their duty station will be monitored and recorded. To
determine the long-term effects of the administration of teriparatide, study enrollees will
be followed for 1-year post study drug year. this follow-up is to determine the incidence of
drug-related side effects, injury recurrence and/or additional bone stress injury based on
data from the participants' Electronic Medical Record.
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