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Идёт набор NCT06643780

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis

Фаза IV С лечением Sarcopenia in Elderly

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: Denosumab, Zolendronic Acid.
Кому может быть актуально
Состояния в реестре: Sarcopenia in Elderly. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial

Обзор

The objective of this study was to conduct a randomized, double-blind, double-dummy active controlled trial to determine the efficacy of denosumab in treating sarcopenia with underlying osteoporosis.

Подробное описание

Aims:

1. To assess whether receptor activator of nuclear factor-kB ligand (RANKL)-inhibition can treat sarcopenia in osteosarcopenic patients, in terms of appendicular skeletal muscle mass (ASM), handgrip strength, and physical performance. 2. To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.

Вмешательства

  • Препарат Denosumab
    60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
  • Препарат Zolendronic Acid
    5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months

Первичные конечные точки

  • 6-metre walk [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • 5-time chair stand test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Appendicular skeletal muscle mass (ASM) [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Handgrip strength [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Quadriceps muscle strength [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Срок оценки: From enrollment to the end of treatment at 52 weeks]
Вторичные конечные точки (7)
  • Falls [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Fracture [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Quality of life Short Form-36 (SF-36) [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Physical activity scale for elderly (PASE) [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Food frequency questionnaire [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Hospital admissions [Срок оценки: From enrollment to the end of treatment at 52 weeks]
  • Mortality [Срок оценки: From enrollment to the end of treatment at 52 weeks]

Критерии участия

Критерии включения

  • Elderly males or females aged 65 years or older
  • diagnosed with osteosarcopenia (sarcopenia diagnosis based on AWGS 2019 guidelines - low appendicular skeletal muscle mass (ASM) by Dual-energy X-ray absorptiometry (DXA) (M:\<7.0kg/m2, F:\<5.4kg/m2) AND low handgrip strength (M:\<28kg, F:\<18kg) OR low physical performance (6-metre walk: \<1.0m/s or 5-time chair stand test ≥ 12 s); osteoporosis diagnosed based on World Health Organization (WHO) criteria with DXA scan T-score ≤ -2.5)
  • Willing and able to comply with study protocol including follow-up evaluations.

Критерии исключения

  • history of recent fracture i.e., within 3 months
  • history of prior anti-osteoporotic drug
  • disease or medication affecting bone or muscle metabolism
  • Chairbound or bedbound
  • Unable to agree for consent
  • contraindication to drug i.e., Denosumab or Zoledronic Acid
  • Underlying malignancy or disease known to cause cachexia
  • severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min
  • moderate to severe liver failure (Child-Pugh Class B or C).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Chinese University of Hong Kong — Гонконг

Публикации

  • Wong RMY, Wong PY, Liu C, Tang N, Wan RCW, Liu WH, Cui C, Zhang N, Kwok TCY, Law SW, Cheung WH. RANK-ligand inhibition to combat sarcopenia with underlying osteoporosis: a study protocol for a randomized, double-blind, double-dummy, active-controlled trial. Trials. 2025 Aug 4;26(1):269. doi: 10.1186/s13063-025-08976-7. PMID 40760465

Идентификаторы

NCT: NCT06643780 · 2022.555

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗