Clinical trial Recruiting at 4 sites Observational Ages 16 to 35

Bone stress injuries in athletes: how they heal and when to return to sport

Official title: Bone Stress Injury Recovery and Return to Sport: A Natural History Study

Run by HealthPartners Institute · NCT07902401 · Data updated 2026-11-12

This observational study follows athletes with lower-extremity bone stress injuries to see how clinical signs, function, and imaging change over a year as they return to running and sport.

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Quick facts

Study typeObservational
Ages16 Years to 35 Years
SexAll
Enrollment105 (estimated)
SponsorHealthPartners Institute
Academic / other
Drugs / interventionschemotherapy, radiation, prednisone
Locations4 sites (Stanford, California and 3 other locations)
StatusRecruiting
StartedAugust 12, 2025
Main results expectedAugust 12, 2028
Study endsAugust 12, 2028
Registry record updatedOctober 28, 2026
Trial IDNCT07902401 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are male or female runners and athletes aged 16–35 with an MRI-confirmed lower-extremity bone stress injury (tibia, metatarsals 2–4, femoral neck, or femoral shaft) grade 2 or higher.

Probably not a fit

Athletes outside the age range, with non-MRI-confirmed injuries, or with injuries unlikely to heal within a year may see limited benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multisite, prospective cohort study tracks MRI-confirmed tibia, metatarsal, and femoral bone stress injuries in runners and athletes over 12 months. Participants continue usual medical care and follow a standardized, progressive return-to-run plan designed with clinicians and therapists. Researchers will document clinical pain, functional tests, and imaging findings to map how recovery markers evolve and how they relate to reinjury risk. The goal is to identify timing and indicators that best reflect healing and readiness to return to sport. No experimental treatment is given; the study uses the diagnostic MRI as a common reference point for milestones.

Why it matters

Potential benefit: If successful, the findings could clarify which clinical and imaging indicators best predict safe return to sport after a bone stress injury.

How similar studies have gone: Prior work suggests variability in healing indicators and reinjury risk, but standardized, validated return-to-sport metrics are not yet established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosed BSI of the tibia, metatarsal two, three, or four, femoral neck or femoral shaft by MRI, grade two or higher on the Fredericson grading scale7
* Age 16-35 years
* Body Mass Index 17.5-30 kg/m2
* Self-reported minimum of three hours per week of endurance exercise that includes running at least fifteen miles per week during three months prior to injury
* Study enrollment within three weeks of MRI

Exclusion Criteria:

* Self-reported history of endocrine disorder that impacts bone health (e.g., diabetes, hyperthyroidism, or primary hyperparathyroidism)
* Self-reported history of bone disease or other bone disorder (e.g., osteopetrosis, osteogenesis imperfecta, osteomalacia, rickets, Paget's disease, or multiple myeloma)
* Use of thyroid hormone replacement at suppressive doses for a history of thyroid cancer
* History of chemotherapy or radiation treatment for cancer in the past 5 years
* Currently taking or have taken oral glucocorticoids for greater than three months (e.g., prednisone or hydrocortisone)
* Current or prior use of osteoporosis medications (e.g., bisphosphonates, teriparatide)
* Current use of anti-seizure medications (e.g. Phenytoin (Dilantin), Carbamazepine (Tegretol), Phenobarbitol)
* Currently pregnant
* Currently lactating
* Contraindications to MRI
* BSI is planned to be managed operatively
* Tibial BSI on the anterior aspect of the bone
* Participants that are non-English speaking

Where it's running

  • Stanford University
    Stanford, California, United States
    Recruiting
  • TRIA Orthopedic Center
    Bloomington, Minnesota, United States
    Recruiting
  • University of Oregon
    Eugene, Oregon, United States
    Recruiting
  • Canadian Institute of Sport Pacific
    Victoria, British Columbia, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.