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

Primary Purpose

Post Menopausal Osteoporosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mother-of-pearl
Calcium Carbonate
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Menopausal Osteoporosis focused on measuring Mother-of-pearl, Osteoporosis, Ageing, Nutrition Health, Prevention

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Gabriel Montpied
  • Clinique Universitaire de Rhumatologie
  • CH Emile Roux
  • Hôpital Edouard Herriot
  • CH Roanne
  • CHU Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mother-of-pearl

Calcium carbonate

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Tolerance to oral mother-of-pearl powder supplementation
Tolerance will be assessed by collecting digestive disorders
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)
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)

Full Information

First Posted
October 3, 2022
Last Updated
May 31, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT05571514
Brief Title
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Osteoporosis
Keywords
Mother-of-pearl, Osteoporosis, Ageing, Nutrition Health, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicentre, double-blind randomized versus positive comparator study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mother-of-pearl
Arm Type
Experimental
Arm Description
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)
Arm Title
Calcium carbonate
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Mother-of-pearl
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Carbonate
Intervention Description
Calcium carbonate is a source of calcium.
Primary Outcome Measure Information:
Title
Change in bone loss at lumbar site
Description
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 Outcome Measure Information:
Title
Tolerance to oral mother-of-pearl powder supplementation
Description
Tolerance will be assessed by collecting digestive disorders
Time Frame
Baseline from 12 months
Title
Change in bone loss at the upper end of the femur
Description
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
Title
Change in bone remodeling of the femur
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karima BOUSSOUALIM, MD
Phone
(0)4 77 12 76 42
Ext
+33
Email
karima.Boussoualim@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON, CRA
Phone
(0)477829458
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karima BOUSSOUALIM, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Gabriel Montpied
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine MALOCHETGUINAMAND, MD
Facility Name
Clinique Universitaire de Rhumatologie
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe GAUDIN, PhD
Facility Name
CH Emile Roux
City
Le Puy-en-Velay
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin CASTAGNE, MD
First Name & Middle Initial & Last Name & Degree
Adamah AMOUZOUGAN, MD
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland CHAPURLAT, PhD
Facility Name
CH Roanne
City
Roanne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mervyn MUNGROO, MD
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karima BOUSSOUALIM, MD
First Name & Middle Initial & Last Name & Degree
Thierry THOMAS, MD PhD
First Name & Middle Initial & Last Name & Degree
Hubert MAROTTE, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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