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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: f
View:

• Post-menopausal women (50-65y) with risk of becoming osteoporotic

• T-score between -1 and -3

• Absence of fragility fractures history

Locations
Other Locations
France
Hôpital Gabriel Montpied
NOT_YET_RECRUITING
Clermont-ferrand
Clinique Universitaire de Rhumatologie
NOT_YET_RECRUITING
Grenoble
CH Emile Roux
NOT_YET_RECRUITING
Le Puy-en-velay
Hôpital Edouard Herriot
NOT_YET_RECRUITING
Lyon
APHP - Hôpital Cochin
NOT_YET_RECRUITING
Paris
CH Roanne
NOT_YET_RECRUITING
Roanne
CHU Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Adamah AMOUZOUGAN, MD
amadah.amouzougan@chu-st-etienne.fr
(0)477120595
Backup
Florence RANCON, CRA
florence.rancon@chu-st-etienne.fr
(0)477829458
Time Frame
Start Date: 2023-05-12
Estimated Completion Date: 2028-11
Participants
Target number of participants: 200
Treatments
Experimental: Mother-of-pearl
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)
Active_comparator: Calcium carbonate
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)
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov