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Bone Property Testing for Fracture Risk

N/A

Waitlist Available

Led By Tamara Rozental, M.D.

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of skeletal metastasis, primary hyperparathyroidism, Paget's disease, multiple myeloma

Prior fracture in adulthood (>age 18) for healthy controls

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to measure if someone is at risk for breaking a hip or radius. They think that women who have already fractured these bones have different bone properties than those who haven't, and that this new method can identify these differences.

Who is the study for?

This trial is for women who've recently had hip or wrist fractures and men over 50 with similar conditions. It's not for those on long-term steroids, anticonvulsants, or with certain bone diseases. People treated with specific osteoporosis medications in the past 3 years or healthy controls with prior adult fractures are also excluded.

What is being tested?

The study tests a new method called Reference Point Indentation to see if it can predict fracture risk better than standard bone density scans. It involves measuring the properties of cortical bone tissue to identify individuals at higher risk of hip and wrist fractures.

What are the potential side effects?

Since Reference Point Indentation is minimally invasive, side effects may include local discomfort, bruising, or swelling at the test site. The procedure is generally considered safe but might not be suitable for people sensitive to minor medical procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bone metastasis, hyperparathyroidism, Paget's disease, or multiple myeloma.

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I have had a bone fracture as an adult.

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I have been using glucocorticoids for over 3 months or am on anticonvulsants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Cortical bone tissue properties by reference point indentation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Post-menopausal womenExperimental Treatment1 Intervention

We will use the handheld Osteoprobe device to measure cortical bone reference point indentation properties.

Group II: Males over 50 yearsExperimental Treatment1 Intervention

We will recruit males to this second study arm, to use the handheld Osteoprobe device to measure cortical bone reference point indentation properties.

0 / 3Eligibility criteria met