Impact of Mother-of-pearl Supplement on Preventing Osteoporosis in Post-menopausal Women
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
This study tests whether taking mother-of-pearl supplements can help prevent osteoporosis in post-menopausal women aged 50 to 65 who are at risk for the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 7 sites (Clermont-Ferrand and 6 other locations) |
| Trial ID | NCT05571514 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of mother-of-pearl supplementation on preventing osteoporosis in post-menopausal women aged 50 to 65 who are at risk of developing the condition. The approach involves administering powdered mother-of-pearl, which is believed to provide calcium supplementation and promote bone health through its anti-resorptive and osteoanabolic properties. Participants will be monitored for changes in bone density and overall bone health over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women aged 50-65 with a T-score between -1 and -3 and no history of fragility fractures.
Not a fit: Patients with conditions affecting bone metabolism or those on conflicting treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a novel nutritional approach to prevent osteoporosis and reduce fracture risk in post-menopausal women.
How similar studies have performed: While the use of nutritional supplements for osteoporosis prevention is common, the specific use of mother-of-pearl is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand and 6 other locations
- Hôpital Gabriel Montpied — Clermont-Ferrand, France (Not_yet_recruiting)
- Clinique Universitaire de Rhumatologie — Grenoble, France (Not_yet_recruiting)
- CH Emile Roux — Le Puy-en-Velay, France (Not_yet_recruiting)
- Hôpital Edouard Herriot — Lyon, France (Not_yet_recruiting)
- APHP - Hôpital Cochin — Paris, France (Not_yet_recruiting)
- CH Roanne — Roanne, France (Not_yet_recruiting)
- CHU Saint-Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Adamah AMOUZOUGAN, MD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Adamah AMOUZOUGAN, MD
- Email: amadah.amouzougan@chu-st-etienne.fr
- Phone: (0)477120595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.