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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2021-A01034-37 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-of-pearl | Experimental | 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) |
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| Calcium carbonate | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mother-of-pearl | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline from 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance to oral mother-of-pearl powder supplementation | Tolerance will be assessed by collecting digestive disorders | Baseline from 12 months |
| Change in bone loss at the upper end of the femur |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adamah AMOUZOUGAN, MD | Contact | (0)477120595 | +33 | amadah.amouzougan@chu-st-etienne.fr |
| Florence RANCON, CRA | Contact | (0)477829458 | +33 | florence.rancon@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Adamah AMOUZOUGAN, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gabriel Montpied | Not yet recruiting | Clermont-Ferrand | France |
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multicentre, double-blind randomized versus positive comparator study
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Stratified randomization :
The study will be double-blinded to avoid follow-up bias and assessment bias. The maintenance of the blind will be guaranteed by the fact that the capsules of mother-of-pearl will be indistinguishable from those of CaCO3 (same shape, same color, same weight). Only the internal use pharmacies (IUP) of each center will be open, for the attribution of the treatment.
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| Calcium Carbonate | Dietary Supplement | Calcium carbonate is a source of calcium. |
|
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)
| 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) | Baseline from 12 months |
| Clinique Universitaire de Rhumatologie | Not yet recruiting | Grenoble | France |
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| CH Emile Roux | Not yet recruiting | Le Puy-en-Velay | France |
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| Hôpital Edouard Herriot | Not yet recruiting | Lyon | France |
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| APHP - Hôpital Cochin | Not yet recruiting | Paris | 75014 | France |
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| CH Roanne | Not yet recruiting | Roanne | France |
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| CHU Saint-Etienne | Recruiting | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D060734 | Nacre |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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