ClinicalTrials.gg
RecruitingNCT07902401Updated Oct 28, 2026

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

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

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
16 Years to 35 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Bone Stress Fracture

Keywords

  • Athlete
  • Runner
  • Bone Stress Injury
  • Return to Sport
  • Bone Healing
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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
  • 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

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 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
  • to MRI
  • BSI is planned to be managed operatively
  • Tibial BSI on the anterior aspect of the bone
  • Participants that are non-English speaking
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • BSI

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

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. Clinical Severity Score_1

    Clinical severity score at time point 1

    Time frame: Clinical severity score at time point 1 (up to 8 weeks)

  9. Clinical Severity Score_2

    Clinical severity score at time point 2

    Time frame: Clinical severity score at time point 2 (up to 12 weeks)

07

Study locations

4 of 4 sites recruiting
08

References and documents

Publications

  • Robertson GA, Wood AM. Return to sports after stress fractures of the tibial diaphysis: a systematic review. Br Med Bull. 2015 Jun;114(1):95-111. doi: 10.1093/bmb/ldv006. Epub 2015 Feb 21. PubMed 25712999 ↗
  • Popp KL, Ackerman KE, Rudolph SE, Johannesdottir F, Hughes JM, Tenforde AS, Bredella MA, Xu C, Unnikrishnan G, Reifman J, Bouxsein ML. Changes in Volumetric Bone Mineral Density Over 12 Months After a Tibial Bone Stress Injury Diagnosis: Implications for Return to Sports and Military Duty. Am J Sports Med. 2021 Jan;49(1):226-235. doi: 10.1177/0363546520971782. Epub 2020 Dec 1. PubMed 33259223 ↗
  • Nattiv A, Kennedy G, Barrack MT, Abdelkerim A, Goolsby MA, Arends JC, Seeger LL. Correlation of MRI grading of bone stress injuries with clinical risk factors and return to play: a 5-year prospective study in collegiate track and field athletes. Am J Sports Med. 2013 Aug;41(8):1930-41. doi: 10.1177/0363546513490645. Epub 2013 Jul 3. PubMed 23825184 ↗
  • Fredericson M, Bergman AG, Hoffman KL, Dillingham MS. Tibial stress reaction in runners. Correlation of clinical symptoms and scintigraphy with a new magnetic resonance imaging grading system. Am J Sports Med. 1995 Jul-Aug;23(4):472-81. doi: 10.1177/036354659502300418. PubMed 7573660 ↗
  • Rizzone KH, Ackerman KE, Roos KG, Dompier TP, Kerr ZY. The Epidemiology of Stress Fractures in Collegiate Student-Athletes, 2004-2005 Through 2013-2014 Academic Years. J Athl Train. 2017 Oct;52(10):966-975. doi: 10.4085/1062-6050-52.8.01. Epub 2017 Sep 22. PubMed 28937802 ↗
  • Hoenig T, Ackerman KE, Beck BR, Bouxsein ML, Burr DB, Hollander K, Popp KL, Rolvien T, Tenforde AS, Warden SJ. Bone stress injuries. Nat Rev Dis Primers. 2022 Apr 28;8(1):26. doi: 10.1038/s41572-022-00352-y. PubMed 35484131 ↗

Individual participant data

Plan to share: No — This trial is observational it doesn't meet ICMJE criteria for requiring an IPD-sharing plan.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07902401
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Aug 12, 2025
Primary completion
Aug 12, 2028 (estimated)
Completion
Aug 12, 2028 (estimated)
Last update
Oct 28, 2026

Study contacts

Kristy Popp, PhD
Contact
Kristy.L.Popp@HealthPartners.Com
952-806-5603
Elizabeth Whitcomb
Contact
triaresearch@tria.com
952-806-5603

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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