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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Post-menopausal women (50-65y) with risk of becoming osteoporotic - T-score between -1 and -3 - Absence of fragility fractures history Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Post-menopausal women (50-65y) with risk of becoming osteoporotic * T-score between -1 and -3 * Absence of fragility fractures history Exclusion Criteria: * 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

Treatments Being Tested

DIETARY_SUPPLEMENT

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 in rat, where mother-of-pearl supplementation showed a better effect on limitation of bone loss than calcium carbonate supplementation.

DIETARY_SUPPLEMENT

Calcium Carbonate

Calcium carbonate is a source of calcium.

Locations (7)

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