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Activo, sin reclutamientoNCT03076034Registro de ClinicalTrials.gov

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

Distal Radius Fracture · Osteoporosis · Hip Fractures

LO ESENCIAL

De qué trata este estudio

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Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
50 años - 100 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
190 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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).

Leer la descripción completa

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.

¿Quién podría participar?

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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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
Sin asignación al azar
Enmascaramiento
Sin enmascaramiento
Post-menopausal women

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

Device: Reference Point Indentation

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

Reference Point Indentation DEVICE

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Cortical bone tissue properties by reference point indentation

Plazo: Day 1

Osteoprobe measurement

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

Plazo: Day 1

DXA at the hip and spine

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

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1 centros

Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
Beth Israel Deaconess Medical Center
Inicio del estudio
26 ene 2015 Real
Finalización primaria
8 ago 2028 Estimado
Finalización del estudio
2030-11 Estimado
Primera publicación
9 mar 2017 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026