[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483167":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":37,"studyPopulation":23,"armGroups":38,"interventions":51,"overallOfficials":60,"centralContacts":64,"locations":74,"responsibleParty":165,"collaborators":167,"id":171,"slug":23,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":172,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":23,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":152,"whyStopped":23,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nMeasurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry)","Baseline from 12 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Tolerance to oral mother-of-pearl powder supplementation","Tolerance will be assessed by collecting digestive disorders",{"measure":18,"description":19,"timeFrame":12},"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)",{"measure":21,"description":22,"timeFrame":12},"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)",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","multicentre, double-blind randomized versus positive comparator study","PREVENTION",{"masking":30,"maskingDescription":31,"whoMasked":32},"QUADRUPLE","Stratified randomization :\n\nThe 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.",[33,34,35,36],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nOur hypothesis is that powdered mother-of-pearl supplementation limits bone loss in postmenopausal women with risk of becoming osteoporotic.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Mother-of-pearl","EXPERIMENTAL","Patient randomized in the \"Mother-of-pearl\" group :\n\nMother of pearl supplementation: 2 capsules of 400mg = 800mg mother of pearl\u002Fday, equivalent to 320mg Ca\u002Fday\n\n\\- Vitamin D: 50,000 IU\u002Fmonth (standard practice)",[44],"Dietary Supplement: Mother-of-pearl",{"label":46,"type":47,"description":48,"interventionNames":49},"Calcium carbonate","ACTIVE_COMPARATOR","Patient randomized in the \"Calcium carbonate\" control group :\n\nCalcium carbonate supplementation: 2 capsules of 400mg= 800mg CaCO3\u002Fday, equivalent to 320mg Ca\u002Fday\n\n\\- Vitamin D: 50,000 IU\u002Fmonth (standard practice)",[50],"Dietary Supplement: Calcium Carbonate",[52,56],{"type":53,"name":40,"description":54,"armGroupLabels":55,"otherNames":23},"DIETARY_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.\n\nThe 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.",[40],{"type":53,"name":57,"description":58,"armGroupLabels":59,"otherNames":23},"Calcium Carbonate","Calcium carbonate is a source of calcium.",[46],[61],{"name":62,"affiliation":5,"role":63},"Adamah AMOUZOUGAN, MD","PRINCIPAL_INVESTIGATOR",[65,70],{"name":62,"role":66,"phone":67,"phoneExt":68,"email":69},"CONTACT","(0)477120595","+33","amadah.amouzougan@chu-st-etienne.fr",{"name":71,"role":66,"phone":72,"phoneExt":68,"email":73},"Florence RANCON, CRA","(0)477829458","florence.rancon@chu-st-etienne.fr",[75,90,101,114,127,139,150],{"facility":76,"status":77,"city":78,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Hôpital Gabriel Montpied","NOT_YET_RECRUITING","Clermont-Ferrand","France","FR",{"type":82,"coordinates":83},"Point",[84,85],3.08682,45.77969,{"lat":85,"lon":84},[88],{"name":89,"role":63,"phone":23,"phoneExt":23,"email":23},"Sandrine MALOCHET GUINAMAND, MD",{"facility":91,"status":77,"city":92,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Clinique Universitaire de Rhumatologie","Grenoble",{"type":82,"coordinates":94},[95,96],5.71479,45.17869,{"lat":96,"lon":95},[99],{"name":100,"role":63,"phone":23,"phoneExt":23,"email":23},"Philippe GAUDIN, PhD",{"facility":102,"status":77,"city":103,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"CH Emile Roux","Le Puy-en-Velay",{"type":82,"coordinates":105},[106,107],3.88523,45.04366,{"lat":107,"lon":106},[110,112],{"name":111,"role":63,"phone":23,"phoneExt":23,"email":23},"Benjamin CASTAGNE, MD",{"name":62,"role":113,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"facility":115,"status":77,"city":116,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hôpital Edouard Herriot","Lyon",{"type":82,"coordinates":118},[119,120],4.84789,45.74906,{"lat":120,"lon":119},[123,125],{"name":124,"role":63,"phone":23,"phoneExt":23,"email":23},"Roland CHAPURLAT, PhD",{"name":126,"role":113,"phone":23,"phoneExt":23,"email":23},"Mathilde PRORIOL, MD",{"facility":128,"status":77,"city":129,"state":23,"zip":130,"country":79,"countryCode":80,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"APHP - Hôpital Cochin","Paris","75014",{"type":82,"coordinates":132},[133,134],2.3488,48.85341,{"lat":134,"lon":133},[137],{"name":138,"role":63,"phone":23,"phoneExt":23,"email":23},"Karine BRIOT, PhD",{"facility":140,"status":77,"city":141,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"CH Roanne","Roanne",{"type":82,"coordinates":143},[144,145],4.06802,46.03624,{"lat":145,"lon":144},[148],{"name":149,"role":63,"phone":23,"phoneExt":23,"email":23},"Mervyn MUNGROO, MD",{"facility":151,"status":152,"city":153,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"CHU Saint-Etienne","RECRUITING","Saint-Etienne",{"type":82,"coordinates":155},[156,157],4.39,45.43389,{"lat":157,"lon":156},[160,161,163],{"name":62,"role":63,"phone":23,"phoneExt":23,"email":23},{"name":162,"role":113,"phone":23,"phoneExt":23,"email":23},"Thierry THOMAS, MD PhD",{"name":164,"role":113,"phone":23,"phoneExt":23,"email":23},"Hubert MAROTTE, MD PhD",{"type":166,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[168],{"name":169,"class":170},"Ministry of Health, France","OTHER_GOV","100483167",false,"NCT05571514","Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis","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","NUTRANACRE","Inclusion Criteria:\n\n* Post-menopausal women (50-65y) with risk of becoming osteoporotic\n* T-score between -1 and -3\n* Absence of fragility fractures history\n\nExclusion Criteria:\n\n* absence of parathyroid glands (phospho-calcic regulation)\n* presence of kidney stones\n* patients who follow a treatment that could interfere with bone metabolism (corticotherapy, menopausal hormonal therapy, anti-oestrogen treatment, non-controlled hyperthyroiditis, hyper- and hypothyroiditis)\n* bone diseases (Paget'disease, osteomalacia)\n* chronic alcoholism","FEMALE","50 Years","65 Years",{"count":182,"type":183},200,"ESTIMATED","INTERVENTIONAL",[186],"NA","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.\n\nGiven 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.",[189],"Post Menopausal Osteoporosis",[40,191,192,193,194],"Osteoporosis","Ageing","Nutrition Health","Prevention","2025-06-18",{"date":197,"type":198},"2025-06-19","ACTUAL",{"date":200,"type":198},"2023-05-12",{"date":202,"type":183},"2028-11",{"name":5,"class":6},7]