Post Menopausal Osteoporosis Clinical Trial
— NUTRANACREOfficial 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | November 2028 |
Est. primary completion date | November 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Gabriel Montpied | Clermont-Ferrand | |
France | Clinique Universitaire de Rhumatologie | Grenoble | |
France | CH Emile Roux | Le Puy-en-Velay | |
France | Hôpital Edouard Herriot | Lyon | |
France | CH Roanne | Roanne | |
France | CHU Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Tolerance to oral mother-of-pearl powder supplementation | Tolerance will be assessed by collecting digestive disorders | Baseline from 12 months | |
Secondary | 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 | |
Secondary | 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 |
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