Bone Property Testing for Fracture Risk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

190 Participants Needed

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).

Will I have to stop taking my current medications?

The trial requires that you have not been treated with certain medications like bisphosphonates, estrogen, teriparatide, calcitonin, or SERMs in the past 3 years, and you should not have used glucocorticoids continuously for more than 3 months or anticonvulsants. If you are currently on these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Reference Point Indentation for assessing fracture risk?

Reference Point Indentation (RPI) is a promising tool for measuring bone strength and fracture risk. Studies show it can distinguish between patients with and without fractures by measuring how much the bone indents under pressure, which is linked to bone's ability to resist fractures. ^{1 2 3 4 5}

Is Reference Point Indentation (RPI) safe for humans?

The Reference Point Indentation (RPI) technique, used to measure bone properties, has been tested in humans and is generally well tolerated. It involves a probe that makes small indentations in the bone, and studies have shown it to be feasible and reproducible for clinical use. ^{2 3 4 5 6}

How does this treatment differ from other treatments for fracture risk?

This treatment uses a novel technique called reference point indentation (RPI) to directly measure the mechanical properties of bone tissue in vivo, which is unique because it allows for the assessment of bone strength without the need for invasive procedures or excising bone samples, unlike traditional methods. ^{1 2 3 4 7}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of cortical bone tissue properties and bone mineral density using Osteoprobe and DXA

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in bone tissue properties and fracture risk

4 weeks

Treatment Details

Interventions

• N/A
• Reference Point Indentation

Trial Overview 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.

Participant Groups

Group I: Post-menopausal women Experimental Treatment 1 Intervention

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

Group II: Males over 50 years Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Bone material strength is associated with areal BMD but not with prevalent fractures in older women. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Microindentation for in vivo measurement of bone tissue mechanical properties in humans. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Clinical measurements of bone tissue mechanical behavior using reference point indentation. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Towards a standardized reference point indentation testing procedure. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Variability in reference point microindentation and recommendations for testing cortical bone: maximum load, sample orientation, mode of use, sample preparation and measurement spacing. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Reference point indentation is insufficient for detecting alterations in traditional mechanical properties of bone under common experimental conditions. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Variability in reference point microindentation and recommendations for testing cortical bone: location, thickness and orientation heterogeneity. [2022]