Bone Property Testing for Fracture Risk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Bisphosphonates, Estrogen, Teriparatide, others

Disqualifiers: Skeletal metastasis, Hyperparathyroidism, Paget's, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to predict who might be at risk for bone fractures, specifically in the hip and wrist. It evaluates bone quality using a handheld device called the Osteoprobe, which employs a technique known as Reference Point Indentation, instead of standard bone density tests. The trial seeks post-menopausal women and men over 50 who have recently experienced a fracture in these areas, as well as those without fractures for comparison. Those who have had a recent hip or wrist fracture might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve fracture risk prediction.

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 prior data suggests that this method is safe for measuring bone properties?

Research has shown that the method used to measure bone properties, called reference point indentation, is generally safe and well-tolerated. In one study, women in the Geelong Osteoporosis Study found this procedure comfortable.

Another study found that the device used, known as the Osteoprobe, carries some risks, but these can be managed with the right precautions. The technique, called impact microindentation, has been reviewed and is considered safe for measuring bone material properties.

Overall, early findings suggest that using the Osteoprobe to measure bone properties is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the handheld Osteoprobe device in assessing fracture risk because it offers a unique and direct way to measure bone strength through reference point indentation. Unlike traditional methods that rely on bone density scans, this technique focuses on the mechanical properties of the bone itself, potentially providing a more accurate prediction of fracture risk. This could lead to better-targeted treatments and preventive strategies for populations like post-menopausal women and older men, who are at a higher risk for fractures.

What evidence suggests that this method is effective for identifying fracture risk?

This trial will use Reference Point Indentation (RPI) to assess bone strength in different groups. Research has shown that RPI could be a useful tool for evaluating bone strength. Studies have found that RPI can detect changes in bone properties, potentially identifying individuals at higher risk for fractures. This method measures bone strength, providing more information than standard bone density tests. Some early research suggests that RPI could detect bone weaknesses before they lead to fractures. While RPI appears promising, further studies are needed to confirm its effectiveness in predicting fracture risk. ^{5 6 7 8 9}

Who Is on the Research Team?

Tamara Rozental, M.D.

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3563255/

Reference-Point Indentation Correlates with Bone Toughness ... Fracture risk is a great concern in numerous populations and RPI testing might be a new technique by which early detection of reduced bone material ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4825864/

True gold or pyrite: A review of reference point indentation ... Nearly a decade ago, reference point indentation (RPI) emerged as an innovative way to potentially assess mechanical properties of bone in vivo. Beginning with ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jbmr.2497

Bone Tissue Properties Measurement by Reference Point ... Here, we tested whether the reference point indentation technique could detect bone tissue property changes early after glucocorticoid treatment initiation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751616118308592

Modeling of Osteoprobe indentation on bone In this paper, the Osteoprobe indentation on a cortical bone is modeled computationally to gain insights into the physical interpretation of the BMSi output.

5. researchgate.net researchgate.net/publication/280629634_True_Gold_or_Pyrite_A_Review_of_Reference_Point_Indentation_for_Assessing_Bone_Mechanical_Properties_In_Vivo

A Review of Reference Point Indentation for Assessing ... Taken together, RPI technology has shown promising results, yet much more work is needed to determine if its theoretical potential to assess ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10556274/

Safety Outcomes of Impact Microindentation: A Prospective ... Impact microindentation (IMI) is a technique to assess bone material properties of the cortical bone at the tibia in a transcutaneous, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9968254/

Reference Intervals for Bone Impact Microindentation in ... Healthy reference intervals for BMSi were identified as 71.0 to 97.9 for men and 59.8 to 95.2 for women.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210013.pdf

den210013 decision summary - accessdata.fda.gov The table below identifies the risks to health that may be associated with use of a bone indentation device and the measures necessary to mitigate these risks.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2352187223000797

The practicality of using bone impact microindentation in a ... Results of this study showed that the IMI technique is well tolerated and accepted by women participating in the Geelong Osteoporosis Study.