Active — Not RecruitingNot Applicable

Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk

United States190 participantsStarted 2015-01-26

Plain-language summary

The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).

Who can participate

Age range

50 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with hip and wrist fractures within 2 weeks of presentation * Non-fracture controls Exclusion Criteria: * Unable to undergo BMD by DXA or high-resolution peripheral quantitative computed tomography (HR-pQCT) * History of skeletal metastasis, primary hyperparathyroidism, Paget's disease, multiple myeloma * Treatment with bisphosphonate, estrogen (within previous 3 years), teriparatide therapy, calcitonin, selective estrogen receptor modulator (SERMs,within previous 3 years) * Use of glucocorticoids continuously for more than 3 months, use of anticonvulsants * Prior fracture in adulthood (\>age 18) for healthy controls Amendment to protocol added Arm 2, to include males \>50 years with otherwise similar eligibility criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cortical bone tissue properties by reference point indentation

Timeframe: Day 1

Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA)

Timeframe: Day 1

Trial details

NCT IDNCT03076034

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-08

View on ClinicalTrials.gov More Distal Radius Fracture trials