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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Post Menopausal Osteoporosis

Treatments: Dietary Supplement: Mother-of-pearl; Dietary Supplement: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT05571514

ANSM (Other Identifier)

20PH256

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Mother-of-pearl

Experimental group

Description:

Patient randomized in the "Mother-of-pearl" group : Mother of pearl supplementation: 2 capsules of 400mg = 800mg mother of pearl/day, equivalent to 320mg Ca/day - Vitamin D: 50,000 IU/month (standard practice)

Treatment:

Dietary Supplement: Mother-of-pearl

Calcium carbonate

Active Comparator group

Description:

Patient randomized in the "Calcium carbonate" control group : Calcium carbonate supplementation: 2 capsules of 400mg= 800mg CaCO3/day, equivalent to 320mg Ca/day - Vitamin D: 50,000 IU/month (standard practice)

Treatment:

Dietary Supplement: Calcium Carbonate