An observational study in Bone Stress Fracture, sponsored by HealthPartners Institute. Recruiting at 4 sites in 2 countries. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by HealthPartners Institute · Observational
Lower extremity bone stress injury (BSI) is a common overuse injury in athletes and typically requires 4-12 weeks rehabilitation time, provided the injury does not require surgery. Current BSI treatment strategies include cessation of load-bearing sporting activities, consideration for crutches and/or immobilization, pain management, and a gradual return to activities until symptoms resolve. Premature return to sport can result in risk of complications and reinjury of the healing BSI. Moreover, our prior work reported that 1/3 of women with a tibial BSI will sustain at least one additional BSI within one year, indicating that current return to sport guidelines may be inadequate. However, there are no gold standard or validated clinical, functional or imaging outcomes that are consistently used to assess BSI healing and guide return to sport. In this prospective observational study, the investigators will enroll male and female athletes with a diagnosed BSI. The investigators will utilize diagnostic imaging, blood samples, and questionnaires to identify primary and secondary outcomes for assessing BSI healing in runners. Our long-term goal is to identify whether biomarkers, health and lifestyle factors, and training patterns associated with future BSI have the potential to inform and improve BSI treatment.
Bone stress injuries (BSIs) result from the accumulation of repetitive skeletal loading that exceeds the bone's capacity for repair. Although magnetic resonance imaging (MRI) is commonly used to diagnose and grade BSIs, there is no accepted standard for determining when an injury has healed sufficiently for an athlete to resume running or unrestricted sport. Previous studies have used measures such as pain-free hopping, pain-free running, completion of a return-to-run program, medical clearance, clinical examination findings, and changes on MRI. However, these measures have not been applied consistently, and their relative time courses and relationships with subsequent injury are not well understood.
This multisite, prospective observational cohort study follows athletes for one year after an MRI-confirmed lower-extremity BSI. The study does not assign an investigational treatment. Participants continue to receive clinical care for their injury and are provided with a standardized, progressive return-to-run framework developed with clinicians and physical therapists experienced in treating runners with BSIs. The primary purpose of the study is to characterize the time course and variability of candidate clinical, functional, and imaging indicators of BSI recovery. Using the date of the diagnostic MRI as a common reference point will allow recovery milestones to be evaluated consistently across participants and injury locations.
Participants complete an initial study visit shortly after diagnosis and return for follow-up assessments during the early recovery period. The timing of follow-up visits differs for femoral-neck injuries because these injuries generally require a longer period of recovery. Study assessments include serial symptom and functional surveys, standardized clinical severity assessments, and repeat MRI of the injured site. Participants report their progression through the return-to-run program in a training diary and complete brief electronic surveys during recovery. After completion of the return-to-run program, participants are contacted monthly through the one-year follow-up to identify any clinically diagnosed subsequent BSI.
Additional assessments are used to explore biological, behavioral, and mechanical factors that may be associated with recovery or subsequent injury. A fasting blood sample collected at baseline is used to measure clinical markers related to bone health and bone metabolism and to conduct exploratory serum protein analyses. Validated questionnaires assess eating attitudes, risk factors for low energy availability, sleep, symptoms of depression and anxiety, and body appreciation. After recovery, a single-leg hopping assessment is used to estimate lower-extremity movement characteristics and loading of the injured and uninjured limbs. Participants who already use a compatible Garmin smartwatch may optionally authorize collection of activity, running, heart-rate, and sleep data.
Analyses will first describe the distribution, timing, and variability of the candidate recovery indicators for the overall cohort and by injury location and sex. Exploratory analyses will evaluate whether recovery indicators, baseline biomarkers, questionnaire measures, training patterns, or movement characteristics are associated with a clinically diagnosed subsequent BSI during the one-year follow-up. Return-to-run adherence will also be described, and sensitivity analyses will examine whether results differ after accounting for adherence. Because the study is intended to characterize recovery and generate estimates for future research rather than test the efficacy of an intervention, enrollment is based on recruitment feasibility rather than a formal hypothesis-testing power calculation.
HealthPartners Institute is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants enrolling at TRIA will be identified by sports medicine clinicians who are participating in this study, and others in the HealthPartners system and on our study team. Clinicians will provide a brief description of the study to potential participants and give them information about who to contact to get additional information about the study or gain permission to share patient contact information with project coordinators for enrollment screening. Patients may also be recruited through clinicians in the greater Minneapolis medical community, through fliers, through targeted social media ads, newsletter, or word of mouth. The investigators may also contact athletic trainers and coaches at colleges in the area to identify potentially eligible athletes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Male and female runners with a recent diagnosis of a bone stress injury.
Single leg hopping
Number of days from diagnostic MRI to pain free single leg hopping
Time frame: Days from diagnostic MRI to achievement of pain free hopping (up to 12 months)
One mile jog
Number of days from MRI diagnosis to pain free one mile jogging
Time frame: Number of days from MRI diagnosis to pain free one mile jogging (up to 12 months)
Thirty minutes jogging
Number of days from diagnostic MRI to pain free thirty minutes jogging
Time frame: Number of days from diagnostic MRI to pain free thirty minutes jogging (up to 12 months)
Completion of return to run protocol
Number of days from diagnostic MRI to completion of return to run protocol
Time frame: Number of days from diagnostic MRI to completion of return to run protocol (up to 12 months)
Medical clearance
Number of days from diagnostic MRI to medical clearance for unrestricted physical activity
Time frame: Number of days from diagnostic MRI to medical clearance for unrestricted physical activity (up to 12 months)
MRI Grade_1
Change in MRI grade from diagnosis to time point 1
Time frame: Change in MRI grade from diagnosis to time point 1 (up to 8 weeks)
MRI Grade_2
Change in MRI grade from diagnosis to time point 1
Time frame: Change in MRI grade from diagnosis to time point 1 (up to 8 weeks)
Clinical Severity Score_1
Clinical severity score at time point 1
Time frame: Clinical severity score at time point 1 (up to 8 weeks)
Clinical Severity Score_2
Clinical severity score at time point 2
Time frame: Clinical severity score at time point 2 (up to 12 weeks)
Plan to share: No — This trial is observational it doesn't meet ICMJE criteria for requiring an IPD-sharing plan.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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