Distal Radius FractureNCT03076034
Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
A study testing Reference Point Indentation in people with Distal Radius Fracture and Osteoporosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Osteoporosis, Hip Fractures
- What is being tested?
- Reference Point Indentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2015to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with hip and wrist fractures within 2 weeks of presentation
- Non-fracture controls
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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).
Read the 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.
- Conditions
- Distal Radius Fracture, Osteoporosis, Hip Fractures
- Being tested
- Reference Point Indentation
- Medical subject headings
- Wrist Fractures, Osteoporosis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference Point IndentationDevice
Also called Osteoprobe
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-menopausal women | Experimental | We will use the handheld Osteoprobe device to measure cortical bone reference point indentation properties. Receives: Device: Reference Point Indentation |
| Males over 50 years | Experimental | We will recruit males to this second study arm, to use the handheld Osteoprobe device to measure cortical bone reference point indentation properties. Receives: Device: Reference Point Indentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical bone tissue properties by reference point indentation
Osteoprobe measurement
Measured: Day 1
Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA)
DXA at the hip and spine
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start26 Jan 2015
- Primary completion8 Aug 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Observational
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Tamara Rozental, Beth Israel Deaconess Medical Center
- Investigators
- Tamara Rozental, M.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076034
- Sponsor's protocol ID
- 2014P000226
- Status last verified
- Oct 2025
- First submitted
- 6 Mar 2017
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
- ClinicalTrials.gov ID
- NCT03076034
- Acronym / sponsor ID
- 2014P000226
- Conditions
- Distal Radius Fracture, Osteoporosis, Hip Fractures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 26 Jan 2015 (actual)
- Primary completion
- 8 Aug 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Observational
| Arm | Type | Receives |
|---|---|---|
| Post-menopausal women | Experimental | Device: Reference Point IndentationWe will use the handheld Osteoprobe device to measure cortical bone reference point indentation properties. |
| Males over 50 years | Experimental | Device: Reference Point IndentationWe will recruit males to this second study arm, to use the handheld Osteoprobe device to measure cortical bone reference point indentation properties. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with hip and wrist fractures within 2 weeks of presentation
- Non-fracture controls
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference Point IndentationAlso: OsteoprobeThe "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. | Device | Males over 50 years, Post-menopausal women |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Rozental, M.D. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference Point Indentation in people with Distal Radius Fracture and Osteoporosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical bone tissue properties by reference point indentation (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.