Clinical trial NCT03076034: Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
Official title: Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Osteoporosis
Hip Fractures
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2017-03-09
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Observational
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cortical bone tissue properties by reference point indentation
timeFrame: Day 1
measure: Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Tamara Rozental, M.D.
role: PRINCIPAL_INVESTIGATOR
References: