Bone Property Testing for Fracture Risk

Recruiting in Palo Alto (17 mi)

Overseen byTamara Rozental, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Tamara Rozental, M.D.

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

Inclusion Criteria

People without any bone fractures.

I am a woman who has had a hip or wrist fracture in the last 2 weeks.

I am a man over 50 years old and meet the other study requirements.

Exclusion Criteria

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

I have been treated with bone-strengthening drugs or hormone therapies in the last 3 years.

You cannot have a bone density scan using DXA or HR-pQCT.

See 2 more

Treatment Details

Interventions

N/A (Corticosteroid)
Reference Point Indentation (Procedure)

Trial OverviewThe 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.

Participant Groups

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.