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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 35 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | HealthPartners Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 4 sites (Stanford, California and 3 other locations) |
| Status | Recruiting |
| Started | August 12, 2025 |
| Main results expected | August 12, 2028 |
| Study ends | August 12, 2028 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07902401 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
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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
- Study coordinator: Kristy Popp, PhD
- Email: Kristy.L.Popp@HealthPartners.Com
- Phone: 952-806-5603
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.