Clinical trial NCT05571514: Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Menopausal Osteoporosis
Keywords: Mother-of-pearl
Osteoporosis
Ageing
Nutrition Health
Prevention
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-10-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentre, double-blind randomized versus positive comparator study
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bone loss at lumbar site
timeFrame: Baseline from 12 months
Secondary outcomes:
measure: Tolerance to oral mother-of-pearl powder supplementation
timeFrame: Baseline from 12 months
measure: Change in bone loss at the upper end of the femur
timeFrame: Baseline from 12 months
measure: Change in bone remodeling of the femur
timeFrame: Baseline from 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Grenoble
country: France
facility: Clinique Universitaire de Rhumatologie
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Roanne
country: France
facility: CH Roanne
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Adamah AMOUZOUGAN, MD
role: PRINCIPAL_INVESTIGATOR
References: