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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Menopausal Osteoporosis
• Intervention / Treatment: Dietary supplement: Mother-of-pearl; Dietary supplement: Calcium Carbonate

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karima BOUSSOUALIM, MD; Phone Number: +33 (0)4 77 12 76 42; Email: karima.Boussoualim@chu-st-etienne.fr
• Study Contact Backup: Name: Florence RANCON, CRA; Phone Number: +33 (0)477829458; Email: florence.rancon@chu-st-etienne.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Not yet recruiting
    • Hôpital Gabriel Montpied
    • Contact: Sandrine MALOCHETGUINAMAND, MD
  • Grenoble, France
    • Not yet recruiting
    • Clinique Universitaire de Rhumatologie
    • Contact: Philippe GAUDIN, PhD
  • Le Puy-en-Velay, France
    • Not yet recruiting
    • Ch Emile Roux
    • Principal Investigator: Benjamin CASTAGNE, MD
    • Sub-Investigator: Adamah AMOUZOUGAN, MD
  • Lyon, France
    • Not yet recruiting
    • Hôpital Edouard Herriot
    • Contact: Roland CHAPURLAT, PhD
  • Roanne, France
    • Not yet recruiting
    • CH Roanne
    • Contact: Mervyn MUNGROO, MD
  • Saint-Étienne, France
    • Recruiting
    • CHU Saint-Etienne
    • Sub-Investigator: Thierry THOMAS, MD PhD
    • Sub-Investigator: Hubert MAROTTE, MD PhD
    • Principal Investigator: Karima BOUSSOUALIM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mother-of-pearl; 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; 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.
Active Comparator: Calcium carbonate; 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; Calcium carbonate is a source of calcium.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Karima BOUSSOUALIM, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Ageing; Prevention; Osteoporosis; Mother-of-pearl; Nutrition Health
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: 20PH256; ANSM (Other Identifier: 2024-A00286-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No