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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-65
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

T-score between -1 and -3

Absence of fragility fractures history

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Calcium Carbonate

    Dietary supplement

    Calcium carbonate is a source of calcium.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Mother-of-pearlExperimental treatment 1 intervention
Group B: Calcium carbonateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Tolerance to oral mother-of-pearl powder supplementation

Tolerance will be assessed by collecting digestive disorders

Time frame
Baseline from 12 months
2

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
3

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

Other outcomes

Sponsors and contacts

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