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Идёт набор NCT07083531

Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait Sickle Cell Trait

— Наблюдательное Sickle Cell Disease Sickle Cell Trait

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Healthy volunteers without SCT, Healthy volunteers with SCT.
Кому может быть актуально
Состояния в реестре: Sickle Cell Disease, Sickle Cell Trait. Базовые параметры: от 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait

Обзор

This is a cross-sectional, clinical research study comparing postmenopausal women of African Descent (AD) with different hemoglobin genotypes: normal and sickle cell trait (SCT). This research study has two purposes. The first purpose is to determine whether having SCT is a risk factor for the development of bone thinning in older women. The second purpose is to investigate whether women with SCT have reduced muscle function and increased frailty compared to women without SCT. The investigators estimate enrolling 50 female volunteers who are at least 50 years old and have not had a menstrual period for at least 12 consecutive months. Volunteers need not know whether they have SCT as this will be evaluated as part of the study.

Подробное описание

This is a collaborative project involving three different disciplinary areas, including The Division of Hematology/Oncology, The Division of Endocrinology, and The Center on Aging (CoA)/Geriatrics in the UConn School of Medicine. The project consists of two specific aims: (1) determine effects of SCT on bone mineral density in postmenopausal women of African descent and (2) investigate the association of SCT on skeletal muscle function and frailty in postmenopausal women of African descent. The investigators hypothesize that individuals with SCT have reduced bone mineral density, decreased muscle function, and increased frailty compared to controls. This research may identify a hitherto unrecognized risk factor for racially disparate fracture incidence and outcomes in AD women. These findings will set the basis for a more extensive clinical study directly examining the association of SCT on fracture incidence and fracture-related morbidity and mortality.

Вмешательства

  • Другое Healthy volunteers without SCT
    Participants will donate blood for serum bone turnover markers, complete blood count, calcium, phosphorus, albumin, parathyroid hormone, and hemoglobin electrophoresis. Participants will undergo a bone density evaluation and muscle mass measurement via dual-energy x-ray absorptiometry (DEXA) scanning. Participants will fill out dietary calcium intake and pain burden questionnaires. Participants will fill out a survey for frailty assessment, undergo 6-minute walk gait velocity and short physical
  • Другое Healthy volunteers with SCT
    Participants will donate blood for serum bone turnover markers, complete blood count, calcium, phosphorus, albumin, parathyroid hormone, and hemoglobin electrophoresis. Participants will undergo a bone density evaluation and muscle mass measurement via dual-energy x-ray absorptiometry (DEXA) scanning. Participants will fill out dietary calcium intake and pain burden questionnaires. Participants will fill out a survey for frailty assessment, undergo 6-minute walk gait velocity and short physical

Первичные конечные точки

  • Difference in bone mineral density between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) [Срок оценки: Day 1]
Вторичные конечные точки (6)
  • Difference in 25-OH vitamin D between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) [Срок оценки: Day 1]
  • Difference in calcium between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) [Срок оценки: Day 1]
  • Difference in parathyroid hormone between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) [Срок оценки: Day 1]
  • Effect of sickle cell trait (SCT) on frailty in older African descent (AD) women [Срок оценки: Day 1]
  • Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women [Срок оценки: Day 1]
  • Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women. [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Female of African Decent.
  • Age 50 years or older.
  • Lack of menstrual period for at least 12 consecutive months

Критерии исключения

  • Taking medications known to influence bone metabolism (e.g., glucocorticoids, hormonal therapy, cancer or chemotherapy meds, anti-resorptive medications or anabolic therapies).
  • Known metabolic bone disorder (e.g., uncontrolled thyroid disease, hyperparathyroidism, Vitamin D deficiency)
  • Taking an investigational drug
  • Documented sickle cell disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • UConn Health — Farmington

Идентификаторы

NCT: NCT07083531 · 22-327-1

Первоисточники (государственные реестры)

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