Enabling clinicians to directly quantify bone quality

OsteoProbe® is a portable handheld impact microindenter that measures the ability of bone material to resist indentation. Unlike radiological or imaging methods (X-ray, DXA and CT) that measure bone mineral density and bone mineral structure, OsteoProbe® measures bone material quality, which is an independent component of bone strength. OsteoProbe® is for research use only in the United States.

OsteoProbe® uses Reference Point Indentation (RPI) technology to investigate the bone material’s ability to resist a localized force (resist separation of mineralized collagen fibrils). This is quantified by the Bone Material Strength index (BMSi) or Bone Score™.

How OsteoProbe Quantifies Quality

OsteoProbe® utilizes a needle-like tip specifically designed for making subcutaneous measurements without the need for an incision. The tip penetrates through the soft tissue down to the bone surface where it establishes a localized reference point. Once a preload threshold is reached, OsteoProbe automatically triggers a second actuation of higher force that performs the official measurement. Indentation depth as a function of force is recorded and then normalized to a calibrated reference material to calculate a Bone Score™.

This chart contains example data and has no clinical significance.

What is the Bone Score?

Once a patient is measured, the device displays that patient's Bone Score™.

Measuring your Bone Score™ is a new service physicians can perform to quantify bone quality. The results are in an easy to understand scale that ranges from 40 to 100.

Patients with healthy bone quality score higher on the scale. Unhealthy patients score lower. Once the physician completes the procedure, they can determine the best next steps for their patients.

Studies show that certain treatments and exercise can improve your Bone Score™ rapidly.

Clinical research is ongoing to accurately define the healthy reference interval for the Bone Score™.

How do you use OsteoProbe?

OsteoProbe uses a single-use sterilized tip to measure bone material quality without an incision. The measurement process is straight forward:

Step 1 - Apply local anesthetic

Percutaneous measurements are made at the mid-shaft of the left or right tibia. After cleaning the region, apply a local anesthetic to numb the skin and periosteium.

Step 2 - Perform measurement

Insert through skin

Place a single-use sterilized tip on the OsteoProbe and insert through the skin to the tibia surface.

Compress housing

Compress the outer housing of the OsteoProbe.

Impact the bone

When fully compressed, the device impacts the bone at a constant force and measures the indentation distance increase from the impact.

Step 3 - Measure reference material

After the software indicates measurements on the patient are complete, measure the reference material that was provided with the single-use tip to calculate the patient's Bone Score™.

Clinical Evidence and Research

OsteoProbe has been extensively tested in clinical research studies covering a wide range of indications. As the technique becomes more common, further refinement and improvement of the test will be possible.

Clinical Publications

Type 2 Diabetes

In Vivo Assessment of Bone Quality in Postmenopausal Women with Type 2 Diabetes
2014 Journal of Bone and Mineral Research – Mayo Clinic – Sundeep Khosla

Dr. Khosla's group found that compared to controls, T2D patients had significantly lower Bone Scores (BMSi): unadjusted (−11.7%; p<0.001). No significant differences were found for BMD.

Advanced Glycation Endproducts and Bone Material Strength in Type 2 Diabetes
2016 Journal of Clinical Endocrinology and Metabolism – Columbia – Dr Mishaela Rubin

Dr. Rubin's group found that Bone Scores (BMSi) were reduced by 9.2% in T2D (P = .02) and was inversely associated with the duration of T2D (r = −0.68, P = .004). There were no differences in BMD.

Type 2 Diabetes Mellitus Is Associated With Better Bone Microarchitecture But Lower Bone Material Strength and Poorer Physical Function in Elderly Women: A Population‐Based Study
2017 Journal of Bone and Mineral Research – Gothenberg Univ – Dr Mattias Lorentzon

Dr. Lorentzon's group found that women with T2DM (n = 99) had higher aBMD compared to controls (n = 954) and ultradistal tibial and radial trabecular bone volume fraction (+11% and +15%, respectively), distal cortical volumetric BMD (+1.6% and +1.7%), cortical area (+11.5% and +9.3%), and failure load (+7.7% and +12.9%) were also higher in diabetics than in controls. Bone Scores (BMSi) were significantly lower in diabetics than controls (74.6 ± 7.6 versus 78.2 ± 7.5, p < 0.01).

 

Monitoring Bone Quality

Bone Tissue Properties Measurement by Reference Point Indentation in Glucocorticoid-Induced Osteoporosis
2015 Journal of Bone and Mineral Research – Hospital del Mar – Dr Adolfo Diez Perez
 

Dr. Diez-Perez's group found that Calcium+Viatmin D treated patients exhibited substantial and significant deterioration in their Bone Score (BMSi), risedronate-treated patients exhibited no significant change, and both denosumab- and teriparatide-treated participants exhibited significantly improved Bone Scores in just 7 weeks after initial treatment compared with baseline; these trends remained stable for 20 weeks. There were no significant changes in BMD.

Fracture during oral bisphosphonate therapy is associated with deteriorated bone material strength index
2017 Bone – Hospital del Mar – Dr Adolfo Diez Perez 

Dr. Diez-Perez's group found that Bone Scores (BMSi) was significantly lower (mean ± SD) in those patients on long term bisphosphonates who fractured (73.76 ± 6.49) than those in no-fracture patients (81.64 ± 6.26; p = 0.001). ROC analyses showed an area under the curve of 0.82 (95% CI 0.68 to 0.95) for the Bone Score, higher than that for BMD at any location.

High Impact Mechanical Loading Increases Bone Material Strength in Postmenopausal Women — a 3‐Month Intervention Study
2018 Journal of Bone and Mineral Research - Dr. Mattias Lorentzon
 

Dr. Lorentzon's group enrolled elderly women to jump on one leg and monitored them with OsteoProbe. They found that, relative to the control leg, the Bone Score (BMSi) increased 7% or 0.89 SD (p = 0.046) but no differences were seen for any of the XtremeCT‐derived bone parameters. This shows that a unilateral high‐impact loading program improved the Bone Score in postmenopausal women rapidly without affecting bone microstructure, geometry or density.

 

Bone Fragility

Are the High Hip Fracture Rates Among Norwegian Women Explained by Impaired Bone Material Properties?
2015 Journal of Bone and Mineral Research – Oslo Univ – Dr Erik Eriksen

Dr. Eriksen's group found that the Bone Scores (BMSi) of Norwegian women was significantly inferior when compared to Spanish women (77 ± 7.1 versus 80.7 ± 7.8, p < 0.001) while total hip BMD was significantly higher in Norwegian women (1.218 g/cm(2) versus 0.938 g/cm(2) , p < 0.001). This suggests that impaired bone material properties (Bone Score) may further enhance the risk of fracture.

Bone Material Strength as Measured by Microindentation In Vivo Is Decreased in Patients With Fragility Fractures Independently of Bone Mineral Density
2015 Journal of Clinical Endocrinology and Metabolism – Leiden Univ – Dr Socrates Papapolous

Dr. Papapoulous' group found Bone Score (BMSi) values were lower in patients with a fragility fracture compared with non-fracture patients (79.9 ± 0.6 vs 82.4 ± 1.0; P = .032) despite similar BMD. In patients with osteopenia, Bone Scores were significantly lower in fracture patients than in non-fracture patients (80.3 ± 0.7 vs 83.9 ± 1.2; P = .015).

Bone material strength is associated with areal BMD but not with prevalent fractures in older women
2015 Journal of Bone and Mineral Research – Gothenberg – Dr Mattias Lorentzon

Dr. Lorentzon's group found that in a randomized population of elderly women (aged 78.3 ±1.1) Bone Scores were associated with aBMD but not with prevalent fracture. They discuss that in some clinical situations, Bone Scores (BMSi) may play a more predominant role in decreasing bone strength, like younger individuals with fragility fractures, diabetes, or incident use of glucocorticoids.

Reduced Bone Material Strength is Associated with Increased Risk and Severity of Osteoporotic Fractures. An Impact Microindentation Study
2017 Calcified Tissue International – Oslo Univ – Dr Erik Eriksen

Dr. Eriksen's group found that subjects with osteoporotic fractures exhibited lower Bone Scores (BMSi) than controls (71.5 ± 7.3 vs. 76.4 ± 6.2, p < 0.001). After adjusting for age and hip BMD, a significant negative correlation was seen between Bone Scores and vertebral fracture severity (r 2 = 0.19, p = 0.007).

Bone material strength index as measured by impact microindentation is low in patients with fractures irrespective of fracture site
2017 Osteoporos International – Leiden Univ – Dr Socrates Papapolous

Dr. Papapoulous' group found that Bone Scores (BMSi) were lower in fracture patients compared to controls with low bone mass, irrespective of whether they sustained a vertebral fracture or a non-vertebral fracture (VF+/Fx− vs Control (VF−/Fx)−; p = 0.004, VF+/Fx+ vs Control (VF−/Fx); p = 0.001, VF−/Fx+ vs Control (VF−/Fx); p < 0.001).

Bone Material Strength Index as Measured by Impact Microindentation in Postmenopausal Women With Distal Radius and Hip Fractures
2017 Journal of Bone and Mineral Research - Beth Israel Deaconess Medical Center and Harvard Medical School - Dr Mary Bouxsein

Dr. Bouxsein's group found that lower BMSi was associated with increased risk of distal radius fracture (unadjusted OR=1.43; 95% CI: 1.02-2.00, per SD decrease, p=0.04), and remained statistically significant after adjustment for age. She also found lower BMSi tended to be associated with hip fracture, but only reached borderline significance (unadjusted OR=1.39; 95% CI: 0.96-2.01, p=0.08).

 

Procedural Overview / Safety

Technical note: Recommendations for a standard procedure to assess cortical bone at the tissue-level in vivo using impact microindentation
2016 Bone – Bone Reports – Collaboration of KOLs

Multiple key opinion leaders wrote a technical note about how to use OsteoProbe in the clinic.

Clinical experience with microindentation in vivo in humans
2016 Bone – Bone Reports – Dr Adolfo Diez Perez

Dr. Diez-Perez summarized the overall experience with OsteoProbe in the clinic.

 

Kidney Transplant

Bone density, microarchitecture, and material strength in chronic kidney disease patients at the time of kidney transplantation
2017 Osteoporos International – Hospital del Mar – Dr Adolfo Diez Perez

Dr. Diez-Perez's group characterized multiple parameters regarding chronic kidney disease patients compared to controls. Among the parameters measured, Bone Scores (BMSi) were found to be significantly lower (79 [71.8–84.2] vs 82. [77.5–88.9] (adjusted p = 0.005)) compared to controls.

Bone Density, Microarchitecture, and Tissue Quality Long-term After Kidney Transplant
2017 Transplantation – Hospital del Mar – Dr Adolfo Diez Perez

Dr. Diez-Perez's group followed up with kidney transplant patients after long-term transplant. They found that despite persistent decrease in BMD, trabecular microarchitecture and tissue quality (Bone Scores) remain normal in long-term KTR, suggesting important recovery of bone health.

 

Other Topics

A High Amount of Local Adipose Tissue Is Associated With High Cortical Porosity and Low Bone Material Strength in Older Women
Adipose Tissue – 2015 Journal of Bone and Mineral Research – Gothenberg – Dr Mattias Lorentzon

Dr. Lorentzon's group found that fat mass was independently and inversely associated with Bone Scores (BMSi) and Ct.vBMD, but positively associated with Ct.Po, indicating a possible adverse effect of adipose tissue on bone quality and bone microstructure.

Women with previous stress fractures show reduced bone material strength
2016 Acta Orthopaedica– Oslo Univ – Dr Erik Eriksen

Dr. Eriksen's group found that Bone Scores (BMSi) in stress fracture patients was significantly lower than in the controls (SD 72 (8.7) vs. 77 (7.2); p = 0.02). There was no correlation with BMD.  Lower Bone Scores in patients with previous stress fracture combined with a lower BMD may contribute to the increased propensity to develop stress fractures in these patients.

HIV Infection Is Associated With Worse Bone Material Properties, Independently of Bone Mineral Density.
2016 Journal of Acquired Immune Deficiency Syndrome – Hospital del Mar – Dr Adolfo Diez Perez

Dr. Diez-Perez's group found that HIV infection is associated with bone damage (decreased Bone Scores), independently of BMD.

Bone Density, Microarchitecture, and Tissue Quality After Long-Term Treatment With Tenofovir/Emtricitabine or Abacavir/Lamivudine
2017 Journal of Acquired Immune Deficiency Syndrome – Hospital del Mar – Dr Adolfo Diez Perez

Dr. Diez-Perez's group found lower Bone Scores (BMSi) and thus poorer bone properties in the TDF-FTC group than in the ABC-3TC group [beta coefficient −3.594 (confidence interval: 95% −0.12 to −7.61); P = 0.043]. Long-term treatment with TDF-FTC leads to impaired bone health, not only in terms of BMD but also in terms of bone quality, another determinant of overall bone strength.

Assessment of Bone Health in Patients With Type 1 Gaucher Disease Using Impact Microindentation
2017 Journal of Bone and Mineral Research  – Hospital del Mar – Dr Adolfo Diez Perez

Dr. Diez-Perez's group found that GD1 was associated with significantly lower Bone Scores (BMSi) (adjusted beta –9.30; 95% CI, –15.18 to –3.42; p = 0.004) and reduced lumbar BMD (adjusted beta –0.14; 95% CI, –0.22 to –0.06; p = 0.002) and total hip BMD (adjusted beta –0.09; 95% CI, –0.15 to –0.03; p = 0.006), compared to GD1‐free controls. Bone disorder requires special consideration in this group of patients, and microindentation (OsteoProbe) could be an appropriate tool for assessing and managing their bone health.

Bone Material Strength index as measured by impact microindentation is altered in patients with acromegaly
2017 EJE – Leiden Univ – Dr Socrates Papapolous

Dr. Papapoulous' group found that tissue-level properties (Bone Scores) of cortical bone are significantly altered in patients with controlled acromegaly after reversal of long-term exposure to pathologically high GH and IGF-1 levels. Their findings also suggest that methods other than DXA should be considered to evaluate bone fragility in patients with acromegaly.

 

 

Clinical and Research Sites

OsteoProbe is currently being used both clinically and for research throughout Europe. OsteoProbe is for Research Use Only in the United States and Australia.

European Clinical Sites

Hospital del Mar/Autonomous University - Barcelona, Spain

Leiden University Medical Center - Leiden, Netherlands

Oslo University Medical Center - Oslo, Norway

Sahlgrenska University Hospital - Gothenburg, Sweden

Karolinska University Hospital - Stockholm, Sweden

Odense University Hospital - Odense, Denmark

Rigshospitalet Glostrup - Glostrup, Denmark

Aarhus University Hospital - Aarhus, Denmark

Glostrup Hospital - Copenhagen, Denmark

University Medical Center Hamburg-Eppendorf - Hamburg, Germany

Charité Universitätsmedizin Berlin - Berlin, Germany

Universitätsmedizin Rostock - Rostock, Germany

and growing...

 

United States Research Sites

Mayo Clinic - Rochester, MN

Columbia University - New York, NY

Hospital for Special Surgery - New York, NY

Baylor College of Medicine - Houston, TX

Massachusetts General Hospital - Boston, MA

Beth Israel Deaconess Medical Center - Boston, MA

Vanderbilt University Medical Center - Nashville, TN

Washington University St. Louis - St. Louis, MO

 

Australian Research Sites

Barwon Health Geelong Hospital - Geelong, Australia

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