An interventional study of Mother-of-pearl and Calcium Carbonate in Post Menopausal Osteoporosis, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 7 sites in France. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention
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.
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.
325 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's planned enrollment of 200 is above the median of 110 across 255 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Dietary Supplement: Mother-of-pearl
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)
Dietary Supplement: Calcium Carbonate
The mother-of-pearl, derived from the inner shell of marine molluscs, is composed of calcium carbonate and organic compounds, some of which peptides are active on the bone. The mineralization inducing activity of the molecules extracted from the mother-of-pearl has been shown in vitro. Mother-of-pearl extract also contains molecules that inhibit the resorption activity of osteoclasts. Mother-of-pearl compounds can thus slow bone remodelling as showed in an ovariectomy-induced osteoporosis model in rat, where mother-of-pearl supplementation showed a better effect on limitation of bone loss than calcium carbonate supplementation.
Calcium carbonate is a source of calcium.
Change in bone loss at lumbar site
Demonstrate that oral mother-of-pearl powder supplementation, for 1 year, reduces bone loss at lumbar site in postmenopausal women with risk of becoming osteoporotic, in a better way than oral supplementation with pure CaCO3. Measurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry)
Time frame: Baseline from 12 months
Tolerance to oral mother-of-pearl powder supplementation
Tolerance will be assessed by collecting digestive disorders
Time frame: Baseline from 12 months
Change in bone loss at the upper end of the femur
Evaluate the impact of oral mother-of-pearl powder supplementation, compared to oral supplementation with pure CaCO3, for 1 year, in postmenopausal women on the bone loss at the upper end of the femur Measurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry)
Time frame: Baseline from 12 months
Change in bone remodeling of the femur
Evaluate the impact of oral mother-of-pearl powder supplementation, compared to oral supplementation with pure CaCO3, for 1 year, in postmenopausal women on the bone remodeling Measurement of the change in BMD will be performed by measurement CTX (serum Collagen-telopeptide)
Time frame: Baseline from 12 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Universitaire de Saint Etienne