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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
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.
Calcium carbonate is a source of calcium.
Hôpital Gabriel Montpied
Clermont-Ferrand, France
NOT_YET_RECRUITINGClinique Universitaire de Rhumatologie
Grenoble, France
NOT_YET_RECRUITINGCH Emile Roux
Le Puy-en-Velay, France
NOT_YET_RECRUITINGHôpital Edouard Herriot
Lyon, France
NOT_YET_RECRUITINGAPHP - Hôpital Cochin
Paris, France
NOT_YET_RECRUITINGCH Roanne
Roanne, France
NOT_YET_RECRUITINGCHU Saint-Etienne
Saint-Etienne, France
RECRUITINGChange in bone loss at lumbar site
Demonstrate that oral mother-of-pearl powder supplementation, for 1 year, reduces bone loss at lumbar site in postmenopausal women with risk of becoming osteoporotic, in a better way than oral supplementation with pure CaCO3. Measurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry)
Time frame: Baseline from 12 months
Tolerance to oral mother-of-pearl powder supplementation
Tolerance will be assessed by collecting digestive disorders
Time frame: Baseline from 12 months
Change in bone loss at the upper end of the femur
Evaluate the impact of oral mother-of-pearl powder supplementation, compared to oral supplementation with pure CaCO3, for 1 year, in postmenopausal women on the bone loss at the upper end of the femur Measurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry)
Time frame: Baseline from 12 months
Change in bone remodeling of the femur
Evaluate the impact of oral mother-of-pearl powder supplementation, compared to oral supplementation with pure CaCO3, for 1 year, in postmenopausal women on the bone remodeling Measurement of the change in BMD will be performed by measurement CTX (serum Collagen-telopeptide)
Time frame: Baseline from 12 months
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