Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Cortical bone tissue properties by reference point indentation
Study Overview
Brief Summary
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Post-menopausal women
We will use the handheld Osteoprobe device to measure cortical bone reference point indentation properties.
Intervention: Reference Point Indentation (Device)
Males over 50 years
We will recruit males to this second study arm, to use the handheld Osteoprobe device to measure cortical bone reference point indentation properties.
Intervention: Reference Point Indentation (Device)
Outcomes
Primary Outcomes
Cortical bone tissue properties by reference point indentation
Time Frame: Day 1
Osteoprobe measurement
Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA)
Time Frame: Day 1
DXA at the hip and spine
Secondary Outcomes
No secondary outcomes reported
Investigators
Tamara Rozental
Associate Professor, Harvard Medical School
Beth Israel Deaconess Medical Center