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Набор скоро начнётся NCT07512323

Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency

Фаза II С лечением Frail Elderly Patients Hypogonadal Males Testosterone Replacement Therapy Falls (Accidents) in Old Age

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: Nebido (Testosterone Undecanoate).
Кому может быть актуально
Состояния в реестре: Frail Elderly Patients, Hypogonadal Males, Testosterone Replacement Therapy, Falls (Accidents) in Old Age. Базовые параметры: от 70 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
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

Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency - a Double-blinded, Randomized and Placebo-controlled Intervention Study

Обзор

The purpose of this study is to increase the functional level of the elderly to thereby reduce fall risk, improve motor skills, and increase psychological well-being, as well as to assess whether the restoration of a normal testosterone level contributes to a faster recovery. The effect of testosterone is investigated as measured by physical and mental functional capacity, including cognition, in hypogonadal elderly men with a significant loss of function. The study is aimed at participants who are too weak to participate in the progressive strength training.

Подробное описание

Please see the uploaded study protocol.

Вмешательства

  • Препарат Nebido (Testosterone Undecanoate)
    Testosterone supplementation is given intramuscularly with 1000 mg testosterone undecanoate, which has an effect for approx. 12 weeks, but which can be repeated more frequently between the 1st and 2nd administration. The injection is thus repeated in week 6. 3 injections per trial subject are expected, i.e., in weeks 1, 6, and 16. If the participants are motivated to continue so that long-term effects can be measured, the participants will be asked in week 12 whether they wish to continue to we

Первичные конечные точки

  • Chair-stand test [Срок оценки: At weeks 0, 4 and 20.]
Вторичные конечные точки (9)
  • Measurement of fall frequency and severity [Срок оценки: At weeks 0, 4 and 20.]
  • Balance ability [Срок оценки: At weeks 0, 4 and 20.]
  • Avlund's mobility scale [Срок оценки: At weeks 0, 4 and 20.]
  • Geriatric Depression Scale (GDS) [Срок оценки: At weeks 0, 4 and 20.]
  • Montreal Cognitive Assessment (MoCA) [Срок оценки: At weeks 0, 4 and 20.]
  • Mini Mental State Examination (MMSE) [Срок оценки: At weeks 0, 4 and 20.]
  • Quality of life EQ-5D [Срок оценки: At weeks 0, 4 and 20.]
  • Clinical Frailty Scale (CFS) [Срок оценки: At weeks 0, 4 and 20.]
  • Falls Efficacy Scale - International (FES-I, Fear of falling). Scores range from 16 to 64, and higher scores indicate increased anxiety of having a severe fall accident. [Срок оценки: At weeks 0, 4 and 20.]

Критерии участия

Критерии включения

  • Men aged 70 or over.
  • Living at home in their own home or in sheltered housing.
  • Independent walking function, possibly with a walking aid.
  • Able to perform the chair-stand test a maximum of 8 times in 30 seconds or Timed Up and Go (TUG) of at least 30 seconds.
  • There must be at least 3 symptoms of frailty or objective findings.
  • Serum testosterone < 10 nmol/L as an average of 2 independent measurements at the Center for Growth and Reproduction, Rigshospitalet.

Критерии исключения

  • Known or previous prostate cancer.
  • Abnormally elevated serum PSA (PSA = prostate-specific antigen) corresponding to PSA > 5 ng/ml or PSA > 0.15 ng/ml/cc (relative to prostate size in cubic centimeters (cc)).
  • Hemochromatosis.
  • Heart diseases in the form of: Peri-, myo-, or endocarditis, angina pectoris, severe heart failure (NYHA class III and IV), severe hypertension (systolic BP > 180 or diastolic BP > 105 mmHg after possible antihypertensive treatment). - Resting dyspnea.
  • Liver (ASAT > 2 x upper normal limit) or renal insufficiency (serum creatinine > 200 micromol/l).
  • Severe intractable epilepsy or migraine.
  • Insulin treatment.
  • Previous or current bisphosphonate, fluoride, HRT, SERM, strontium, teriparatide, or more than 3 weeks of prednisolone treatment.
  • Joint disease with acute inflammation.
  • Active cancer disease, in chemo- or radiotherapy.
  • Bone metabolic disease except for age-related osteoporosis.
  • Autoimmune diseases, chronic systemic diseases (cirrhosis, AIDS, chronic renal failure).
  • Primary testosterone deficiency in the form of testicular dysgenesis, Klinefelter syndrome (47,XXY), 46,XX males, LH resistance, Y chromosome deletions, other sex chromosome abnormalities.
  • Significant abuse, mental illness, dementia, physical handicaps with inability to complete the intervention or tests, or to give informed consent.
  • Contraindications for testosterone undecanoate are thus included in exclusion criteria, such as the presence of liver tumors, breast carcinoma, and prostate cancer, for which trial participants will be examined before the start of the trial.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Holbæk Hospital — Holbæk

Идентификаторы

NCT: NCT07512323 · H-16020521

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗