Recruiting

Observational Study

Sponsor:

HealthPartners Institute

Code:

NCT07902401

Conditions

Bone Stress Fracture

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Bone Stress Fracture

Study ID

NCT07902401

Start date

Aug 12, 2025

Status verified date

Oct, 2026

Completion date

Aug 12, 2028

Anticipated

Primary completion date

Aug 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Interventions and Outcome Measures

Arms

BSI

Male and female runners with a recent diagnosis of a bone stress injury.

Primary outcome measure

  • Single leg hopping [ Time Frame: Days from diagnostic MRI to achievement of pain free hopping (up to 12 months) ]
  • One mile jog [ Time Frame: Number of days from MRI diagnosis to pain free one mile jogging (up to 12 months) ]
  • 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 [ Time Frame: Number of days from diagnostic MRI to completion of return to run protocol (up to 12 months) ]
  • Medical clearance [ Time Frame: Number of days from diagnostic MRI to medical clearance for unrestricted physical activity (up to 12 months) ]
  • MRI Grade_1 [ Time Frame: Change in MRI grade from diagnosis to time point 1 (up to 8 weeks) ]
  • MRI Grade_2 [ Time Frame: Change in MRI grade from diagnosis to time point 1 (up to 8 weeks) ]
  • Clinical Severity Score_1 [ Time Frame: Clinical severity score at time point 1 (up to 8 weeks) ]
  • Clinical Severity Score_2 [ Time Frame: Clinical severity score at time point 2 (up to 12 weeks) ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Stanford, California, United States, 94304

Contacts

TRIA Orthopedic Center

Recruiting

Bloomington, Minnesota, United States, 55431

Contacts

Principal Investigator:

Kristy Popp, PhD

University of Oregon

Recruiting

Eugene, Oregon, United States, 97403

Contacts

Principal Investigator:

Mike Hahn, PhD

Canadian Institute of Sport Pacific

Recruiting

Victoria, British Columbia, Canada, V9E 2C5

Contacts

Principal Investigator:

Trent Stellingwerf, PhD

More Information

Sponsor

HealthPartners Institute

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • Athlete
  • Runner
  • Bone Stress Injury
  • Return to Sport
  • Bone Healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by HealthPartners Institute on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.