Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk

Beth Israel Lahey Health

Status: Active, not recruiting

Conditions: Osteoporosis; Hip Fractures; Distal Radius Fracture

Treatments: Device: Reference Point Indentation

Study type: Interventional

Funder types: Other

Identifiers

NCT03076034

2014P000226

Details and patient eligibility

About

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).

Full description

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 BMD. To test these hypotheses, The investigators propose two aims:

Aim 1: Compare cortical bone tissue properties as assessed in vivo by reference point indentation in women with hip fractures and non-fracture controls.

The investigators will compare cortical bone tissue material properties, as assessed by novel in vivo indentation at the mid-tibia in postmenopausal women with recent hip fractures (n) and age-similar controls without fractures (n=). In addition to in vivo indentation measurements, The investigators will assess hip and spine BMD by DXA; as well as other factors that may influence risk of fractures (e.g, vit D status, medication use and physical activity). Hypotheses: Postmenopausal women with hip fractures will have worse bone tissue material properties compared to non-fracture controls even after adjustment for BMD and other potential confounders.

Aim 2: Compare cortical bone tissue properties as assessed in vivo by reference point indentation in women with distal radius fractures to non-fracture controls.

The investigators will compare cortical bone tissue material properties, as assessed by novel in vivo indentation at the mid-tibia in postmenopausal women with recent distal radius fractures (n) and age-similar controls without fractures (n=). In addition to in vivo indentation measurements, The investigators will assess hip and spine BMD by DXA; as well as other factors that may influence risk of fractures (e.g, vit D status, medication use and physical activity). Hypotheses: Postmenopausal women with distal radius fractures will have worse bone tissue material properties compared to non-fracture controls even after adjustment for BMD and other potential confounders.

Successful completion of this project will address the need to better assess bone mechanical properties at the tissue level in order to accurately predict fracture risk. The study will provide novel information about possible clinical utility of minimally invasive, in vivo bone indentation measurements to measure bone strength and its relationship to fracture risk.

Aim 3: An amendment to the protocol expanded the study population to now include males >50 years who present with distal radius fractures and those who present for a reason other than fracture (non-fracture controls). Hypotheses: Men >50 years with distal radius fractures will have worse bone tissue material properties compared to non-fracture controls even after adjustment for BMD and other potential confounders.

Enrollment: 190 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with hip and wrist fractures within 2 weeks of presentation
• Non-fracture controls

Exclusion criteria

• Unable to undergo BMD by DXA or high-resolution peripheral quantitative computed tomography (HR-pQCT)
• History of skeletal metastasis, primary hyperparathyroidism, Paget's disease, multiple myeloma
• Treatment with bisphosphonate, estrogen (within previous 3 years), teriparatide therapy, calcitonin, selective estrogen receptor modulator (SERMs,within previous 3 years)
• Use of glucocorticoids continuously for more than 3 months, use of anticonvulsants
• Prior fracture in adulthood (>age 18) for healthy controls

Amendment to protocol added Arm 2, to include males >50 years with otherwise similar eligibility criteria.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Post-menopausal women

Experimental group

Description:

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

Treatment:

Device: Reference Point Indentation

Males over 50 years

Experimental group

Description:

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

Treatment:

Device: Reference Point Indentation