AzTrials
AzTrials

Bone Stress FractureNCT07902401

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

An observational study of Bone Stress Fracture, run by HealthPartners Institute at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years
Conditions the study is for
Bone Stress Fracture
How many people
105 participants
Where
4 sitesin 2 countries
Study dates
12 Aug 2025to 12 Aug 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

4 sites in 2 countries

United States3 sites, 3 recruiting
  • TRIA Orthopedic Center

    Bloomington, Minnesota, 55431

    Kristy Popp, PhD, 952-806-5603, kristin.l.popp@healtpartners.com

    Elizabeth Whitcomb, 952-806-5603, triaresearch@tria.com

    Recruiting
  • University of Oregon

    Eugene, Oregon, 97403

    Mike Hahn, PhD, 541-870-0862, Mhahn@uoregon.edu

    Zak Kindl, 541-346-2408, Zkindl@uoregon.edu

    Recruiting
  • Stanford University

    Stanford, California, 94304

    Emily Kraus, MD, 308-991-8055, Ekraus@stanford.edu

    Gauri Desai, 513-546-9612, gdesai@stanford.edu

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting
  • Canadian Institute of Sport Pacific

    Victoria, British Columbia, V9E 2C5

    Trent Stellingwerf, PhD, 250.208.6674, Tstellingwerff@csipacific.ca

    Gayatri Raghavan, 778.288.2137, Graghavan@csipacific.ca

    Recruiting

Other trials in Canada

About this study

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.

Keywords
Athlete, Runner, Bone Stress Injury, Return to Sport, Bone Healing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07902401
Study groupRoleWhat they receive
BSIMale and female runners with a recent diagnosis of a bone stress injury.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single leg hopping

    Number of days from diagnostic MRI to pain free single leg hopping

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

  9. Clinical Severity Score_2

    Clinical severity score at time point 2

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start12 Aug 2025
  3. Primary completion12 Aug 2028 (estimated)
  4. Study completion12 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07902401
Sponsor's protocol ID
A25-047
Status last verified
Oct 2026
First submitted
9 Sep 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This trial is observational it doesn't meet ICMJE criteria for requiring an IPD-sharing plan.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Stress Fracture, run by HealthPartners Institute at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristy Popp, PhD (952-806-5603, Kristy.L.Popp@HealthPartners.Com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single leg hopping (time frame: Days from diagnostic MRI to achievement of pain free hopping (up to 12 months)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07902401, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in