Post Menopausal OsteoporosisNUTRANACRENCT05571514
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
A study testing Mother-of-pearl and Calcium Carbonate in people with Post Menopausal Osteoporosis, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Post Menopausal Osteoporosis
- What is being tested?
- Mother-of-pearl and Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 12 May 2023to Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women (50-65y) with risk of becoming osteoporotic
- T-score between -1 and -3
- Absence of fragility fractures history
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
Hôpital Gabriel Montpied
Clermont-Ferrand
Sandrine MALOCHET GUINAMAND, MD
- Not yet recruiting
Clinique Universitaire de Rhumatologie
Grenoble
Philippe GAUDIN, PhD
- Not yet recruiting
CH Emile Roux
Le Puy-en-Velay
Benjamin CASTAGNE, MD
Adamah AMOUZOUGAN, MD
- Not yet recruiting
Hôpital Edouard Herriot
Lyon
Roland CHAPURLAT, PhD
Mathilde PRORIOL, MD
- Not yet recruiting
APHP - Hôpital Cochin
Paris, 75014
Karine BRIOT, PhD
- Not yet recruiting
CH Roanne
Roanne
Mervyn MUNGROO, MD
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Adamah AMOUZOUGAN, MD
Thierry THOMAS, MD PhD
About this study
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
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.
Read the 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.
- Conditions
- Post Menopausal Osteoporosis
- Being tested
- Mother-of-pearl, Calcium Carbonate
- Keywords
- Mother-of-pearl, Osteoporosis, Ageing, Nutrition Health, Prevention
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-of-pearlDietary 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.
Calcium CarbonateDietary supplement
Calcium carbonate is a source of calcium.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline from 12 months
Secondary outcomes (3)
Tolerance to oral mother-of-pearl powder supplementation
Tolerance will be assessed by collecting digestive disorders
Measured: 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)
Measured: 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)
Measured: Baseline from 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start12 May 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, double-blind randomized versus positive comparator study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adamah AMOUZOUGAN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571514
- Sponsor's protocol ID
- 20PH256
- Other IDs
- ANSM
- Acronym
- NUTRANACRE
- Status last verified
- Sep 2026
- First submitted
- 3 Oct 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No