Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

Официальное название

Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis: Multicentre, Double-blind Randomized Versus Positive Comparator Study

Обзор

Post-menopausal osteoporosis and the resulting fractures are an important cause of disability and loss of independence. They also increase the risk of morbidity and mortality. Given potential side effects, hormone replacement therapy is no longer recommended for menopausal women with risk of becoming osteoporotic. The very significant decrease in the use of these treatments is suspected of contributing to a resurgence in the incidence of osteoporotic fractures, particularly in women before the age of 70. There is a need for prevention of osteoporosis.

Подробное описание

Mother-of-pearl is a candidate for long-term use due to the combination of its effects: calcium supplementation, anti-resorptive activity and osteoanabolic activity.

Our hypothesis is that powdered mother-of-pearl supplementation limits bone loss in postmenopausal women with risk of becoming osteoporotic.

Вмешательства

• Пищевая добавка Mother-of-pearl
  The mother-of-pearl, derived from the inner shell of marine molluscs, is composed of calcium carbonate and organic compounds, some of which peptides are active on the bone. The mineralization inducing activity of the molecules extracted from the mother-of-pearl has been shown in vitro. Mother-of-pearl extract also contains molecules that inhibit the resorption activity of osteoclasts. Mother-of-pearl compounds can thus slow bone remodelling as showed in an ovariectomy-induced osteoporosis model
• Пищевая добавка Calcium Carbonate
  Calcium carbonate is a source of calcium.

Первичные конечные точки

• Change in bone loss at lumbar site [Срок оценки: Baseline from 12 months]

Вторичные конечные точки (3)

• Tolerance to oral mother-of-pearl powder supplementation [Срок оценки: Baseline from 12 months]
• Change in bone loss at the upper end of the femur [Срок оценки: Baseline from 12 months]
• Change in bone remodeling of the femur [Срок оценки: Baseline from 12 months]

Критерии участия

Критерии включения

• Post-menopausal women (50-65y) with risk of becoming osteoporotic
• T-score between -1 and -3
• Absence of fragility fractures history

Критерии исключения

• absence of parathyroid glands (phospho-calcic regulation)
• presence of kidney stones
• patients who follow a treatment that could interfere with bone metabolism (corticotherapy, menopausal hormonal therapy, anti-oestrogen treatment, non-controlled hyperthyroiditis, hyper- and hypothyroiditis)
• bone diseases (Paget'disease, osteomalacia)
• chronic alcoholism

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

Профилактика

Центры проведения

Франция · 7 центров

• Hôpital Gabriel Montpied — Clermont-Ferrand
• Clinique Universitaire de Rhumatologie — Grenoble
• CH Emile Roux — Le Puy-en-Velay
• Hôpital Edouard Herriot — Lyon
• APHP - Hôpital Cochin — Paris
• CH Roanne — Roanne
• CHU Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT05571514 · 20PH256 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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