[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-strength\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-strength":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100593723","phase-2-role-of-estrogen-on-skeletal-outcomes-in-fha-100593723",false,"NCT07010146","Role of Estrogen on Skeletal Outcomes in FHA","Role of Estrogen Formulation and Route of Delivery on Skeletal Outcomes in Functional Hypothalmic Amenorrhea","Inclusion Criteria:\n\n* Females, age 14-30 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left)\n* Women of reproductive age: use of an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no systemic skeletal effects) for study duration if sexually active. Note: Women who receive a progestin implant for contraception after study enrollment will be allowed to continue and will not be excluded from study.\n* Biochemical criteria: negative βHCG (pregnancy test), TSH within 2x the upper limit of normal, prolactin \\\u003C10 ng\u002FmL above upper limit of normal, potassium between 3.0-5.0, ALT ≤3 times upper limit of normal, LDL ≤190 mg\u002Fdl.\n* Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a TSH within 2x the upper limit of normal for at least a month preceding the baseline study visit.\n* Menstrual criteria: \\\u003C 3 menses in the preceding 6 months.\n\nExclusion Criteria:\n\n* Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus\n\n  1. Primary thyroid dysfunction will be defined as a TSH level more than 2X the upper limit of normal per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies.\n  2. Patients with hypothyroidism will be excluded if not appropriately treated with levothyroxine and if they do not have a TSH level within 2X the upper limit of normal for at least a month preceding the baseline study visit, given possible effects on the reproductive axis and bone.\n* Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation)\n* Substance use disorder; current smoker (\\>10 cigarettes per day)\n* Pregnant, planning to become pregnant within 12 months of the end of treatment and\u002For breastfeeding\n* Hypertension or use of anti-hypertensive medications\n* Other conditions causing oligo-amenorrhea such as PCOS, premature ovarian insufficiency\n* Known sensitivity or absolute contraindication to any component of study medications (high risk thromboembolic disease, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, acute viral hepatitis, decompensated cirrhosis, undiagnosed abnormal uterine bleeding\n* BMI ≥ 25 kg\u002Fm2 (efficacy of the contraceptive patch being used in the study is lower at higher BMIs)","FEMALE","14 Years","30 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control.\n\nParticipants will:\n\n1. Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin)\n2. Take provided calcium and vitamin D supplements\n3. Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include:\n\n   * History and Physical Exams\n   * Lab Work\n   * Imaging studies\n   * Questionnaires\n   * Dietary recalls",[27,28,29],"Bone Strength","Bone Density","FHA (Functional Hypothalamic Amenorrhea)",[31,32,33,34],"Estrogen","Functional hypothalamic amenorrhea","Transdermal","Oral","RECRUITING","2026-04-15",{"date":38,"type":39},"2026-04-17","ACTUAL",{"date":41,"type":39},"2025-10-01",{"date":43,"type":21},"2030-05-31",{"name":45,"class":46},"University of Virginia","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100585558","phase-2-bone-metabolism-in-12-21-year-olds-undergoing-glucagon-like-peptide-glp-1-receptor-agonist-therapy-100585558","NCT06903923","Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy","Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy","Inclusion Criteria:\n\n* • Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual' care.\n* Diagnosis of obesity (BMI ≥ 95th percentile for age and sex). The FDA has approved the use of GLP-1 RAs (liraglutide and semaglutide) for adolescents ≥ 12 years old with BMI ≥ 95th percentile for age and sex, and tirzepatide for adults with obesity. Those in the GLP-1 RA arm must have demonstrated efforts at weight loss with 'usual' care, and consistent compliance with appointments and recommendations.\n* Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical therapy and implement required behavioral changes\n* Patients taking orlistat as a precursor to GLP-1 RA therapy due to insurance requirements may be included given minimal effects on weight.\n* Use of the following contraceptive methods is permitted: Combine oral contraceptives (COCs); continuous oral progestin; Progestin-releasing intrauterine device (IUD); Progestin implant; transdermal patch.\n* Patients with celiac disease will be included if the condition is well controlled and they are on a gluten free diet with normal 25(OH)D levels confirmed by clinical labs within 3 months of enrollment in the study. If a patient does not have recent 25(OH)D results, we will add this to the screening labs.\n\nExclusion Criteria:\n\n* • Current or previous history of pregnancy and breast feeding.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in the GLP-1 RA group.\n* \\> 5 kg weight loss over 3 months given the known impact of significant weight loss on bone density.\n* Use of dulaglutide and exenatide (of the GLP-1 RAs) given minimal weight loss with these drugs.\n* Use of medications such as metformin, phentermine, or topiramate that may cause weight loss, or obesogenic antipsychotic medications if treated for \\\u003C3 months, or if dosage is not stable for \\>2 months.\n* Medications other than calcium or vitamin D that affect bone, such as systemic glucocorticoids, phenytoin, phenobarbitone (unless there is a washout period of 3 months prior to enrollment if discontinuation is medically permissible)\n* Female participants on hormonal contraception will be excluded if this involves use of depot medroxyprogesterone acetate (DMPA). DMPA has profound deleterious effect on bone density, which could confound study outcomes related to bone health. Rationale: DMPA has a well-documented deleterious effect on bone density, which could confound study outcomes related to bone health or metabolic parameters.\n* Untreated thyroid dysfunction or on stable dose for \\\u003C3 months. Primary thyroid dysfunction will be defined as: a TSH ≥ 10 IU\u002FL or low per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies. Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a normal TSH. For patients with secondary hypothyroidism (deficient production of TSH from the pituitary gland causing hypothyroidism), normal free T4 concentrations (and not TSH alterations) will be used for study inclusion, and recent adjustments in the levothyroxine dose will be permissible as long as free T4 concentrations are in the normal range at dose adjustment (as dose adjustments are often made to get free T4 concentrations in the upper half of the normal range when assessed levels are in the lower half of the normal range). Patients with hyperthyroidism will be excluded given known deleterious effects on both weight and bone metabolism.\n* Medical conditions known to impact weight or bone density, such as chronic gastrointestinal disorders (including inflammatory bowel disease), other inflammatory conditions, such as rheumatoid arthritis or ankylosing spondylitis, untreated thyroid disease, and hypercortisolemia.\n* HbA1C \\>8% (to avoid deleterious effects on bone from uncontrolled T2DM).\n* Smoking \\>10 cigarettes\u002Fday given deleterious effects on bone; substance abuse per DSM-5.\n* Weight \\>450 lbs due to limits for DXA scanners.\n* History of metabolic and bariatric surgery.\n* Judged by the investigators to be inappropriate for the study for other reasons not detailed above.","ALL","12 Years","21 Years",{"count":58,"type":21},120,[24],"The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management.\n\nParticipants will:\n\n* Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss\n* Take provided calcium and vitamin D supplements\n* Attend 6 study visits over 24 months with two at the beginning and then every 6 months that include:\n\n  * History and Physical Exams\n  * Lab Work\n  * Imaging studies\n  * Questionnaires\n  * 24-hour dietary recalls",[62,27,63,64,28,65],"Obesity in Children","GLP - 1","Lifestyle Modification","Obesity",[67,68,69,70,71,72,73,74],"obesity","obesity in children","bone strength","GLP-1","Lifestyle modification","bone density","semaglutide","liraglutide",{"date":38,"type":39},{"date":77,"type":39},"2025-07-31",{"date":79,"type":21},"2030-04-30",{"name":45,"class":46},1]