[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-health":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,51,80,113,141,178,208,235,255],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053953","early-time-restricted-eating-combined-with-exercise-in-older-adults-100053953",false,"NCT07695961","Early Time-Restricted Eating Combined With Exercise in Older Adults","Effects of Early Time-Restricted Eating Combined With a Multicomponent Exercise Program on Bone Mineral Density, Gait, Balance, and Fall Risk in Healthy Older Adults: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 60 years or older\n* Community-dwelling and generally healthy older adults\n* Sedentary or moderately physically active\n* Stable body weight during the previous 3 months (no intentional weight loss or gain \\>5%)\n* Able to participate in a supervised exercise program\n* Willing to comply with the time-restricted eating protocol and study procedures\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of osteoporosis requiring pharmacological treatment\n* Severe sarcopenia or major mobility limitations preventing safe exercise participation\n* Cognitive impairment or diagnosed dementia affecting ability to follow instructions\n* Presence of uncontrolled chronic diseases affecting bone metabolism (e.g., advanced renal disease, uncontrolled endocrine disorders)\n* Current use of medications affecting bone metabolism (e.g., corticosteroids, anti-osteoporotic drugs)\n* Participation in another structured exercise or dietary intervention program within the past 3 months\n* Any medical condition that contraindicates moderate-intensity exercise\n* Inability to comply with study protocol or follow-up assessments",true,"ALL","60 Years","85 Years",{"count":21,"type":22},44,"ESTIMATED","INTERVENTIONAL",[25],"NA","This randomized controlled trial aims to investigate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone health, physical function, and fall risk in healthy older adults.\n\nA total of approximately 44 healthy adults aged 60 years and older will be recruited and randomly assigned to one of two groups. The experimental group will follow an Early Time-Restricted Eating schedule combined with a structured multicomponent exercise program. The control group will not receive any dietary timing intervention or structured exercise program and will continue their usual daily lifestyle.\n\nThe intervention will last for 6 months. Participants in the exercise program will perform supervised sessions including resistance training, balance exercises, aerobic activity, and flexibility exercises. The Early Time-Restricted Eating protocol will involve consuming all daily food intake within an early daytime window while maintaining usual dietary quality and adequate energy and nutrient intake.\n\nThe main outcomes of the study include changes in bone mineral density, gait performance, balance, and fall risk. These outcomes will be measured at baseline and after the intervention period.\n\nThis study will provide evidence on whether combining early time-restricted eating with structured exercise can improve musculoskeletal health and functional ability, and reduce fall risk in older adults.",[28,29,30,31,32],"Nutrition","Health and Wellbeing","Aging","Time Restricted Eating","Bone Health",[31,34,35,36,37],"Exercise Program","Bone Mineral Density","Gait","Balance","NOT_YET_RECRUITING","2026-07-09",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":22},"2026-06-15",{"date":46,"type":22},"2026-12-30",{"name":48,"class":49},"University of Manouba","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":50},"100642298","bone-management-in-pregnancy-outcomes-in-epilepsy-100642298","NCT07651709","Bone Management in Pregnancy Outcomes in Epilepsy","Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study","Inclusion Criteria:\n\n* Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy.\n* Women of childbearing age, aged ≥18 years, planning pregnancy or in early pregnancy (≤16 weeks gestation, confirmed by last menstrual period or ultrasound) - single pregnancy.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Pre-existing conditions affecting bone metabolism: primary hyperparathyroidism, Paget's disease, multiple myeloma, chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin), cirrhosis (Child-Pugh B\u002FC), or untreated hyper\u002Fhypothyroidism.\n* History of metabolic complications: hypercalcemia (serum Ca²⁺ \\>10.5 mg\u002FdL), nephrolithiasis, or granulomatous diseases.\n* Recent\u002Fcurrent use of bone-modifying drugs: bisphosphonates, glucocorticoids (≥5 mg\u002Fday prednisone equivalent for \\>1 month), or loop diuretics within the past year.\n* Ultrasound shows fetal malformation.\n* Presence of other severe systemic diseases deemed unsuitable for study participation by the investigator.","FEMALE","18 Years",{"count":61,"type":22},80,[25],"This study is aimed to evaluate the efficacy of bone health management in improving pregnancy outcomes among WWE, and establish evidence-based vitamin D supplementation strategies for childbearing-age WWE.",[65,66,32],"Epilepsy","Pregnant Woman",[68,69],"epilepsy","pregnancy","RECRUITING","2026-06-11",{"date":73,"type":42},"2026-06-16",{"date":75,"type":22},"2026-06",{"date":77,"type":22},"2035-01",{"name":79,"class":49},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":16,"sex":58,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100642603","fermented-foods-and-bone-health-investigating-the-gut-bone-axis-in-premenopausal-vegan-women-100642603","NCT07645885","Fermented Foods and Bone Health: Investigating the Gut-Bone Axis in Premenopausal Vegan Women","FERMBONE","Inclusion Criteria:\n\n* Female, aged 28-43years.\n* Body mass index (BMI) between 18.5 and 24.9 kg\u002Fm².\n* Premenopausal, with regular menstrual cycles. \\*\n* Adherence to a vegan diet for ≥1 year, confirmed by questionnaire.\n* Willingness to consume both fermented and non-fermented plant-based study foods.\n* Ability to comply with all study procedures, including run-in, washout, sample collection, and clinic visits.\n* Signed written and oral informed consent.\n\n  * Regular menstrual cycles are defined as spontaneous menstrual bleeding occurring every 21-35 days, with cycle-to-cycle variability not exceeding 7-9 days over the prior three months, and bleeding duration of 3-8 days, in the absence of hormonal contraception or endocrine disorders.\n\nExclusion Criteria:\n\n* Chronic diseases or conditions affecting bone metabolism (e.g., osteoporosis, thyroid disorders, chronic kidney and liver disease, menstrual cycles disorders affecting bone health, conditions associated with malabsorption).\n* History of diagnosed eating disorders.\n* Chronic inflammatory or gastrointestinal diseases (e.g., IBD, celiac disease).\n* Recent antibiotic use (within 3 months prior to screening).\n* Use of Vitamin D supplements exceeding 2000 IU\u002Fday.\n* Abnormal DXA results (T-score ≤ -2.5).\n* Pregnancy, intention to become pregnant, or lactation during the course of the study\n* Use of hormonal contraceptives.\n* Use of medications influencing bone metabolism (e.g., glucocorticoids, antiresorptives).\n* BMI \\\u003C18.5 or \\>24.9 kg\u002Fm².\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or anticipated prolonged absence (e.g. extended travel).\n* Participation in another clinical study within the last 3 months.\n* Known allergy or intolerance to study foods.","28 Years","43 Years",{"count":90,"type":22},50,[25],"Plant-based diets are increasingly adopted for health and environmental reasons, but they are associated with lower bone mineral density, higher fracture risk, and elevated bone turnover markers, particularly in women. These effects are partly explained by lower intakes of calcium and zinc, and higher concentrations of phytates and oxalates, substances that inhibit mineral absorption from plant foods. Evidence-based dietary strategies to support bone health in vegan populations beyond supplementation remain limited.\n\nFermented plant-based foods may help address this gap through two complementary mechanisms: first, by delivering live microorganisms that beneficially modulate gut microbiota and promote the production of short-chain fatty acids, which support mineral absorption and reduce bone resorption, and second, by reducing antinutritional factors such as phytates during microbial fermentation, thereby improving mineral bioavailability.\n\nThis study investigates whether the daily consumption of fermented plant-based foods, specifically lacto-fermented vegetables, calcium-fortified plant-based yogurt alternatives with live cultures, and Rhizopus-fermented tempeh, reduces bone resorption and improves calcium metabolism in premenopausal women following a vegan diet. Participants will follow each dietary condition (fermented or matched non-fermented control foods) for 12 weeks in randomized order, separated by an 8-week washout period. Blood, urine, and stool samples are collected at each study visit to assess bone turnover markers, gut microbiota composition, short-chain fatty acid production, inflammatory markers, and a range of metabolic and nutritional parameters.",[94,32],"Bone",[96,97,98,99,100,101,102],"Fermented foods","Bone health","Gut microbiota","Gut-bone axis","Premenopausal women","Plant-based diet","Vegan diet","2026-06-10",{"date":105,"type":42},"2026-06-12",{"date":107,"type":22},"2026-05-31",{"date":109,"type":22},"2027-05-31",{"name":111,"class":49},"Isabelle Herter-Aeberli",2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":16,"sex":58,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":50},"100637190","effect-of-dairy-protein-yogourt-vs-plant-based-yogourt-on-body-weight-body-composition-bone-health-and-gut-microbiota-100637190","NCT07578103","Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota","A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods","PROYO","Inclusion Criteria:\n\n* Postmenopausal women (absence of menstruation for at least 1 year and FSH \\> 40 IU\u002FL)\n* BMI between 27.0 and 39.9 kg\u002Fm²\n* Sedentary or moderately active\n\nExclusion Criteria:\n\n* Body weight change greater than 5 kg in the 3 months preceding the study\n* Currently dieting or following specific dietary patterns\n* Previous or planned bariatric surgery\n* Food allergies or intolerances (particularly dairy proteins and lactose)\n* Serious or problematic health conditions (e.g., renal insufficiency, diabetes, Cushing's disease, Paget's disease, parathyroid disorders, inflammatory bowel disease, uncontrolled thyroid disease, etc.)\n* Fracture within the past year\n* Hormone therapy\n* Medications affecting bone metabolism (e.g., osteoporosis treatments, anti-estrogen therapy for breast cancer, epilepsy treatments)\n* Antibiotic use within the 6 months preceding the study\n* Use of probiotic supplements (capsules)\n* More than two alcoholic drinks per day\n* Smoking\n* Drug abuse","40 Years",{"count":123,"type":22},75,[25],"The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.",[127,128,129,130,32,131],"Body Composition Changes","Body Weight Change","Metabolic Health","Bone Metabolism","Gut Microbiota","2026-05-05",{"date":134,"type":42},"2026-05-11",{"date":136,"type":42},"2023-11-01",{"date":138,"type":22},"2026-12-31",{"name":140,"class":49},"Laval University",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":160,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":4},"100628632","evaluation-of-dora-care-for-supporting-fracture-liaison-services-fls-100628632","NCT07464171","Evaluation of Dora Care for Supporting Fracture Liaison Services (FLS)","A Prospective, Mixed-Methods Feasibility Study to Evaluate the Agreement, Safety, and Acceptability of 'Dora Care', an Automated AI Voice Assistant, for Supporting Clinical Pathways in a Fracture Liaison Service.","Inclusion Criteria:\n\n* Access to and ability to use a telephone for automated conversations as part of a routine, FLS phone pathway. This includes patients who are:\n* Adults aged ≥50 years.\n* Presenting with a new fragility fracture requiring FLS assessment.\n* Able to provide informed consent.\n* English speaking.\n* Reside in the UK.\n\nExclusion Criteria:\n\n* Severe cognitive impairment precluding meaningful telephone interaction or informed consent.\n* Patients already established on long-term osteoporosis treatment.\n* Terminal illness with a life expectancy \\\u003C12 months.\n* Current participation in another clinical trial altering standard of care thus altering the care schedule.","50 Years",{"count":150,"type":22},217,[25],"What is the study about? This study is testing \"Dora\", an AI-powered assistant that can make phone calls to patients, for use in the Fracture Liaison Service (FLS). The FLS is a clinic that helps prevent more bone fractures after an initial \"fragility fracture\" (a break that happens easily, usually due to osteoporosis).\n\nWhy is this being done? FLS clinicians often have to spend a lot of time on routine phone calls for assessments and follow-ups. If Dora can safely and accurately collect patient information, it might save time for staff and still give patients a good experience.\n\nWhat will happen to patients in the study? Invitation and consent - Patients with a new fragility fracture who are eligible will be invited to take part after informed consent.\n\nDora call - Patients will receive an automated phone call from Dora, at the start of their FLS pathway and at follow-up.\n\nAt intake, Dora will ask about risk factors for bone problems (e.g., smoking, alcohol use, family fracture history).\n\nAt follow-up, Dora will ask about medication use, side effects, falls, or new fractures.\n\nClinician call - Soon after, patients will have their usual phone appointment with an FLS clinician, who asks similar questions.\n\nSurveys\u002Finterviews - Patients will be asked to complete a short questionnaire and take part in an optional interview to say how they felt about talking to Dora.\n\nWhat about clinicians? Clinicians involved in the FLS pathway will be asked to complete a short survey and to take part in an optional interview to understand how useful Dora's reports might be in their work.\n\nWho can take part? Patients - Age 50+, English-speaking, with a new fragility fracture, and able to use the phone.\n\nClinicians - Those working in FLS or similar bone health services. How long will it take? Each patient might be involved for up to about 7 months. The whole study will take about a year.",[154,155,156,157,158,159,32],"AI (Artificial Intelligence)","Osteoporosis","Outpatient","Telemedicine","Automation","Risk Assesment",[154,161,162,163,164,165,157,32,166,167],"Fracture Liason Services","Conversational AI","Triage","Rheumatology","Telephone Consultation","Voice AI","Medical Device","2026-03-05",{"date":170,"type":42},"2026-03-11",{"date":172,"type":22},"2026-02",{"date":174,"type":22},"2027-12",{"name":176,"class":177},"Ufonia","INDUSTRY",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":186,"maxAge":59,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":112},"100497194","phase-2-oxytocin-effects-on-bone-in-children-with-autism-spectrum-disorder-100497194","NCT05754073","Oxytocin Effects on Bone in Children With Autism Spectrum Disorder","A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder","BOX","Inclusion Criteria:\n\n1. Ages 6 to 18 years old at Randomization\n2. BMI greater than or equal to the 5th percentile\n3. Expert clinical diagnosis of ASD\n4. Availability of parent\u002Fguardian to provide informed consent\n\nExclusion Criteria:\n\n1. Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect heart or bone density\n2. Other conditions that may contribute to low bone density (e.g., hypogonadism)\n3. Medications that may impact bone other than calcium or vitamin D supplementation, other than calcium or vitamin D supplementation, such as specific anti-seizure medications (Phenytoin, Phenobarbital), oral glucocorticoids, hormonal contraceptive injection (Medroxyprogesterone acetate (Depo-Provera)\n4. Hyponatremia\n5. Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range\n6. Estimated glomerular filtration rate (eGFR) less than 60\n7. Substance use disorder within the last 6 months\n8. History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT (QTc greater than or equal to 480 msec)\n9. Active seizures within 6 months preceding the Screening visit or the Baseline visit\n10. Subjects who are pregnant, lactating, or who refuse contraception if sexually active\n11. Subjects who have had previous treatment with OXT (within 2 months of Randomization)\n12. Subjects who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training\n13. Caregivers who are unable to speak English, be consistently present at study visits to report on symptoms or, per the judgement of the data collection team, are unable to comply with the protocol\n14. Any significant illness, condition, medication, or medical device that the Investigator determines could interfere with study participation and impact data collection or subject safety","6 Years",{"count":188,"type":22},96,[190],"PHASE2","This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.",[193,32],"Autism Spectrum Disorder",[195,196,197,198],"Autism spectrum disorder","Bone density","Oxytocin","Peri-pubertal children","2026-02-26",{"date":201,"type":42},"2026-03-02",{"date":203,"type":42},"2023-08-01",{"date":205,"type":22},"2028-08-31",{"name":207,"class":49},"Elizabeth Austen Lawson",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":218,"phases":4,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":50},"100558161","bone-and-muscle-health-following-sleeve-gastrectomy-in-men-premenopausal-and-postmenopausal-women-100558161","NCT06547515","Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women","BONUS","Inclusion Criteria:\n\n* Men and women aged \\>18 years;\n* Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.\n* Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) \\>40 UI\u002FL.\n* Women taking oral contraceptive pills or hormone replacement therapy\n* Patients with type 2 diabetes.\n\nExclusion Criteria:\n\n* Type 1 diabetes;\n* Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)\n* Metabolic bone disease other than osteoporosis or type 2 diabetes,\n* Creatinine clearance \\\u003C30 ml\u002Fmin) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;\n* Weight \\>204 kg (DXA weight limit) or BMI \\>60 kg\u002Fm2 (upper limit to allow for QCT examination);\n* Current or planned pregnancy during follow-up; breast-feeding.",{"count":216,"type":22},156,"36 Months","OBSERVATIONAL","Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.",[221,32,222,223],"Bariatric Surgery","Severe Obesity","Muscle Health",[225,97,222,223],"bariatric surgery","2025-06-05",{"date":228,"type":42},"2025-06-10",{"date":230,"type":42},"2022-09-14",{"date":232,"type":22},"2026-08-15",{"name":234,"class":49},"CHU de Quebec-Universite Laval",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":18,"enrollmentInfo":242,"targetDuration":4,"studyType":218,"phases":4,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100320748","bone-health-after-bariatric-surgery-in-patients-with-type-2-diabetes-100320748","NCT03455868","Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes","BODI","Inclusion Criteria:\n\n* bariatric groups: men and women; 18 to 60 years old; with a BMI \\>=35 kg\u002Fm2; with type 2 diabetes: use of oral hypoglycemic agents or insulin OR 2 of the following tests confirming type 2 diabetes: HbA1c \\>=6.5%; fasting glucose \\>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \\>=11.1 mM) (guidelines.diabetes.ca);) or without diabetes: HbA1c \\\u003C6.5% AND fasting glucose \\\u003C7.0 mM; who are awaiting bariatric surgery. Control group: BMI 25.0 to 29.9 kg\u002Fm2 (overweight group); without diabetes or prediabetes: HbA1c \\\u003C6.0% AND fasting glucose \\\u003C6.1 mM (Diabetes Canada criteria), with a stable weight for the last 3 months.\n\nExclusion Criteria:\n\n* bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \\\u003C60 ml\u002Fmin) or medication (e.g. glucocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; BMI\\>60 kg\u002Fm2; CT scan impossible to perform (e.g. patient too large for the gantry aperture); pregnant women or women who plan to become pregnant during the study or women of childbearing age who do not agree to take an appropriate contraceptive method during the study; history of oesophageal, gastric or digestive surgery; history of bariatric surgery; cancer at risk of recurrence during the study; Prosthesis that could interfere with interpretation of imaging data; Chronic severe condition or illness precluding from participation in the project.\n\nControl group: Same criteria plus: \\>5% change in weight in the last 3 months; pregnancy or lactation in the last year.",{"count":243,"type":22},100,"Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.",[221,32,246,247],"Obesity, Morbid","Diabetes Mellitus, Type 2",{"date":228,"type":42},{"date":250,"type":42},"2018-03-15",{"date":252,"type":22},"2025-12-01",{"name":234,"class":49},3,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":218,"phases":4,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":4},"100557646","neuroendocrine-regulation-of-bone-fat-crosstalk-in-obesity-100557646","NCT06540820","NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY","Inclusion criteria for subjects with pituitary disease:\n\n* Male and female subject \\> 18-year-old (also fertile patients can be included)\n* Patients with prolactinoma or Cushing disease, Acromegaly or hypogonadism\u002Fhypopituitarism\n* BMI ≥30 Kg\u002Fm2\n* Able to sign an informed consent\n\nInclusion criteria for subjects without pituitary disease\n\n* Male and female subject \\> 18-year-old\n* BMI ≥ 30 Kg\u002Fm2\n* Able to sign an informed consent\n\nExclusion Criteria:\n\n* Male and female subject \\\u003C18-year-old\n* pregnant or breastfeeding women\n* Subject unable to sign informed consent\n* BMI \\\u003C 30 Kg\u002Fm2",{"count":262,"type":22},150,"To study the effect of neuroendocrine dysfunctions on bone health in obesity",[265,266,32],"Obesity; Endocrine","Pituitary Dysfunction","2024-08-02",{"date":269,"type":42},"2024-08-06",{"date":271,"type":22},"2024-09",{"date":273,"type":22},"2025-09",{"name":275,"class":49},"IRCCS San Raffaele"]