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RECRUITING
NCT05571514
NA

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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-05-12

Completion Date

2028-11

Last Updated

2025-06-19

Healthy Volunteers

No

Interventions

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