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

Post Menopausal Osteoporosis Clinical Trial

— NUTRANACRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571514
• Other study ID #: 20PH256
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Karima BOUSSOUALIM, MD
• Phone: (0)4 77 12 76 42
• Email: karima.Boussoualim[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Dietary Supplement:
• Mother-of-pearl
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
Calcium carbonate is a source of calcium.

Locations

Country	Name	City	State
France	Hôpital Gabriel Montpied	Clermont-Ferrand
France	Clinique Universitaire de Rhumatologie	Grenoble
France	CH Emile Roux	Le Puy-en-Velay
France	Hôpital Edouard Herriot	Lyon
France	CH Roanne	Roanne
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerance to oral mother-of-pearl powder supplementation	Tolerance will be assessed by collecting digestive disorders	Baseline from 12 months
Secondary	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
Secondary	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