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

NCT05571514 | Recruiting

• 2 other identifiers: 20PH256ANSM
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Post Menopausal Osteoporosis

Keywords

Mother-of-pearl; Osteoporosis; Ageing; Nutrition Health; Prevention

Outcome Measures

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)

  Baseline from 12 months

Secondary Outcomes (3)

• Tolerance to oral mother-of-pearl powder supplementation

  Baseline from 12 months

• Change in bone loss at the upper end of the femur

  Baseline from 12 months

• Change in bone remodeling of the femur

  Baseline from 12 months

Study Arms (2)

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)

Dietary Supplement: Mother-of-pearl

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)

Dietary Supplement: Calcium Carbonate

Interventions

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.

Mother-of-pearl

Calcium Carbonate DIETARY_SUPPLEMENT

Calcium carbonate is a source of calcium.

Calcium carbonate

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women (50-65y) with risk of becoming osteoporotic
• T-score between -1 and -3
• Absence of fragility fractures history

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (7)

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, 75014, France

NOT YET RECRUITING

CH Roanne

Roanne, France

NOT YET RECRUITING

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Nacre; Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Adamah AMOUZOUGAN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adamah AMOUZOUGAN, MD

CONTACT

(0)477120595; amadah.amouzougan@chu-st-etienne.fr

Florence RANCON, CRA

CONTACT

(0)477829458; florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicentre, double-blind randomized versus positive comparator study

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 7, 2022
• Study Start: May 12, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)