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

What this trial studies

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.

Conditions in scope

• Post Menopausal Osteoporosis

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…
• Calcium Carbonate (Dietary Supplement) — Calcium carbonate is a source of calcium.

Who can join

Women only · Ages 50 Years to 65 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-05-12
• Primary completion: 2027-11
• Last update posted: 2025-06-19
• First posted: 2022-10-07

Sponsor & contact

Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)

Collaborators: Ministry of Health, France

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in bone loss at lumbar site (Baseline from 12 months)
  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)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.