Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Recruiting · NCT05571514 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
Calcium CarbonateMother-of-pearl
What this trial is 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.
Who can take part
Age range
50 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed.
- 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