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A Study to Evaluate Bone Mineral Densities and Serological Markers to Assess Fracture Risk in Children and Young Adults with Bleeding Disorders

Overview

Información sobre este estudio

The primary objectives of this study are to obtain serological bone turnover markers and bone mineral density (BMD) measurements from hemophilia A and von Willebrand disease (VWD) patients aged  ≥ 6 to ≤ 25 years, to compare BMD measurements by HRpQCT and DXA with respect to severity of hemophilia A (mild, moderate, severe) and vWD, annualized bleeding rates, activity and joint scores, and to identify multivariate predictors (correlates) of BMD measurements, including serological bone turnover markers, biochemical and hormonal markers, chronological age, Tanner stage, gender, height, weight, BMI, type of bleeding disorder, severity of bleeding disorder, history of inhibitors, and joint bleeds.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patients ≥ 6 to ≤ 25 years of age.
  • Diagnosed with hemophilia A or vWD.
  • Able to give informed consent (and assent as applicable).

Exclusion Criteria:

  • Patients < 6 or > 25 years of age.
  • No known diagnosis of hemophilia A or vWD.
  • Inability or unwillingness to consent or undergo study activities.
  • Use of medications known to impact bone and mineral metabolism (e.g., bisphosphonates, corticosteroids, estrogens, testosterone therapy, calcitonin, thyroid hormone therapy).
  • Disease known to affect bone integrity (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease).
  • Illicit drug use or alcohol use > 3 drinks/day.
  • Weight > 350 pounds (the maximum weight limit of the DXA).
  • Implanted hardware precluding scans.
  • History of bilateral wrist fracture.
  • Women who are currently pregnant or who become pregnant.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Rajiv Pruthi, M.B.B.S.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20505328

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