Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Post Menopausal Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Mother-of-pearl
* Dietary Supplement: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicentre, double-blind randomized versus positive comparator study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mother-of-pearl<br>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<br>* 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.<br>|
| Active Comparator: Calcium carbonate<br>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<br>* Calcium carbonate is a source of calcium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mother-of-pearl, Osteoporosis, Ageing, Nutrition Health, Prevention