Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- Dietary Supplement: Calcium CarbonateDietary Supplement: Mother-of-pearl
- Registration Number
- NCT05571514
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Post-menopausal women (50-65y) with risk of becoming osteoporotic
- T-score between -1 and -3
- Absence of fragility fractures history
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium carbonate 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) Mother-of-pearl 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)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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)
Trial Locations
- Locations (7)
APHP - Hôpital Cochin
🇫🇷Paris, France
CH Emile Roux
🇫🇷Le Puy-en-Velay, France
Hôpital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Clinique Universitaire de Rhumatologie
🇫🇷Grenoble, France
CH Roanne
🇫🇷Roanne, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
CHU Saint-Etienne
🇫🇷Saint-Étienne, France