NCT03076034

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2015Nov 2028

Study Start

First participant enrolled

January 26, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2026

Expected
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

11.5 years

First QC Date

March 6, 2017

Last Update Submit

October 27, 2025

Conditions

Distal Radius FractureOsteoporosisHip Fractures

Outcome Measures

Primary Outcomes (2)

  • Cortical bone tissue properties by reference point indentation

    Osteoprobe measurement

    Day 1

  • Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA)

    DXA at the hip and spine

    Day 1

Study Arms (2)

Post-menopausal women

EXPERIMENTAL

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

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.

Device: Reference Point Indentation

Interventions

Reference Point IndentationDEVICE

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.

Also known as: Osteoprobe
Males over 50 yearsPost-menopausal women

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Wrist FracturesOsteoporosisHip Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFemoral FracturesHip InjuriesLeg Injuries

Study Officials

  • Tamara Rozental, M.D.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Harvard Medical School

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 9, 2017

Study Start

January 26, 2015

Primary Completion (Estimated)

August 8, 2026

Study Completion (Estimated)

November 1, 2028

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)