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 (NUTRANACRE)

NCT05571514 NA RECRUITING

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.

Details

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	NA
Status	RECRUITING
Enrolment	200
Start date	2023-05-12
Completion	2028-11

Conditions

• Post Menopausal Osteoporosis

Interventions

• Mother-of-pearl
• Calcium Carbonate

Primary outcomes

• Change in bone loss at lumbar site — Baseline from 12 months
  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)

Countries

France