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

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ClinicalTrials.gov Identifier: NCT03076034
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Tamara Rozental, Beth Israel Deaconess Medical Center

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).

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Osteoporosis Hip Fractures Device: Reference Point Indentation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Observational
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
Actual Study Start Date : January 26, 2015
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Post-menopausal women
We will use the handheld Osteoprobe device to measure cortical bone reference point indentation properties.
Device: Reference Point Indentation
The "Osteoprobe": Since these first reports of indentation measurements in humans in vivo, a more 'user-friendly' device, the Osteoprobe® has been developed by Active Life Scientific (Santa Barbara, CA) (10). The Osteoprobe®, which we will use in the current study, is smaller than the previous reference point indentation (RPI) instrument and is designed to be used in a hand-held fashion to allow for rapid measurements. The new instrument does not require a reference probe, because the inertia of the instrument keeps it adequately fixed in space during the short time of the indentation impact (~0.25 milliseconds). The main parameter measured is the distance that the probe further indents into the bone from the reference point. Key components of the Osteoprobe® include an impact generation mechanism, a displacement transducer, and a probe made of hardened stainless steel with a 90 degree conical tip, with a tip diameter of ~375 µm.
Other Name: Osteoprobe

Experimental: 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.
Device: Reference Point Indentation
The "Osteoprobe": Since these first reports of indentation measurements in humans in vivo, a more 'user-friendly' device, the Osteoprobe® has been developed by Active Life Scientific (Santa Barbara, CA) (10). The Osteoprobe®, which we will use in the current study, is smaller than the previous reference point indentation (RPI) instrument and is designed to be used in a hand-held fashion to allow for rapid measurements. The new instrument does not require a reference probe, because the inertia of the instrument keeps it adequately fixed in space during the short time of the indentation impact (~0.25 milliseconds). The main parameter measured is the distance that the probe further indents into the bone from the reference point. Key components of the Osteoprobe® include an impact generation mechanism, a displacement transducer, and a probe made of hardened stainless steel with a 90 degree conical tip, with a tip diameter of ~375 µm.
Other Name: Osteoprobe




Primary Outcome Measures :
  1. Cortical bone tissue properties by reference point indentation [ Time Frame: Day 1 ]
    Osteoprobe measurement

  2. Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA) [ Time Frame: Day 1 ]
    DXA at the hip and spine



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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076034


Contacts
Contact: Tamara Rozental, M.D. 617-667-2627 TRozenta@bidmc.harvard.edu
Contact: Katiri Wagner-Nunes 617.667.3940 KWagner@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Tamara Rozental, M.D.    617-667-2627    TRozenta@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Responsible Party: Tamara Rozental, Associate Professor, Harvard Medical School, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03076034     History of Changes
Other Study ID Numbers: 2014P000226
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Osteoporosis
Radius Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Forearm Injuries
Arm Injuries