Post Menopausal Osteoporosis
Conditions
Keywords
Mother-of-pearl, Osteoporosis, Ageing, Nutrition Health, Prevention
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.
Interventions
DIETARY_SUPPLEMENTMother-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.
DIETARY_SUPPLEMENTCalcium Carbonate
Calcium carbonate is a source of calcium.
Sponsors
Ministry of Health, France
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention model description
multicentre, double-blind randomized versus positive comparator study
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance to oral mother-of-pearl powder supplementation | Baseline from 12 months | Tolerance will be assessed by collecting digestive disorders |
| Change in bone loss at the upper end of the femur | Baseline from 12 months | 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 | Baseline from 12 months | 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) |
Countries
France
Contacts
Primary ContactAdamah AMOUZOUGAN, MD
Backup ContactFlorence RANCON, CRA
Outcome results
None listed