[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578324":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":30,"collaborators":18,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":18,"eligibilityCriteria":40,"healthyVolunteers":41,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":18,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":18},{"fullName":5,"class":6},"Tabriz University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sodium pentaborate pentahydrate","EXPERIMENTAL","In this study, participants in the experimental group will receive 1000 mg of boron daily. OsteoBor will be administered orally, following the dosage recommendations provided by previous studies. Additionally, all participants will receive standard daily doses of 1200 mg of calcium and 800 IU of vitamin D3 supplements.",[13],"Drug: Sodium pentaborate pentahydrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","NO_INTERVENTION","The placebo capsules used in the study will be visually identical to the OsteoBor capsules in terms of appearance and packaging. These capsules will be administered in the same way as the OsteoBor to maintain blinding and ensure that participants are unaware of their group allocation.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","Sodium pentaborate pentahydrate will be administered orally in capsule form, following the standard protocol outlined in the study design.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Saeid Safiri, PhD","CONTACT","00989141005277","saeidsafiri@gmail.com",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr. Saeid Safiri","Dr.","100578324","phase-2-efficacy-of-osteobor-in-postmenopausal-osteoporosis-100578324",false,"NCT06809816","Efficacy of OsteoBor in Postmenopausal Osteoporosis","Efficacy of OsteoBor in Postmenopausal Osteoporosis: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial","Inclusion Criteria:\n\nAge Range: Postmenopausal women aged 45 to 85 years. Menopause status must be confirmed, with at least 1 year since the last menstrual period.\n\nBone Mineral Density (BMD): T-score at the lumbar spine, total hip, or femoral neck should be ≤ -2.5 but \\> -3.5.\n\nGeneral Health: Participants must be generally healthy with no significant chronic diseases that could affect bone health or the assessment of outcomes.\n\nCompliance with OsteoBor: All participants must be willing to adhere to daily intake of OsteoBor or placebo, along with calcium (1200 mg) and vitamin D (800 IU) supplements throughout the study.\n\nInformed Consent: Participants must sign written informed consent before enrolment and confirm their understanding of the study design, interventions, and potential risks.\n\n\\-\n\nExclusion Criteria:\n\nHistory of Fractures: A history of hip fractures or more than one clinical fracture in the spine. Any fractures other than hip fractures (except for fractures of fingers, toes, or the skull) within the past 24 months.\n\nOther Bone Diseases: Presence of metabolic bone disorders other than osteoporosis, such as Paget's disease, osteomalacia, or hyperparathyroidism. Rheumatoid arthritis or other inflammatory joint diseases that could affect bone health.\n\nKidney-Liver Problems \\& Calcium Metabolism: Severe kidney failure, defined as serum creatinine levels above 1.6 mg\u002FdL, or a history of kidney stones. Abnormalities in serum calcium levels, 25-hydroxy vitamin D, or parathyroid hormone (PTH) levels.\n\nProhibited Medications: Use of oral bisphosphonates in the past 6 months or long-term use (more than 6 months) at any time in the past. Any use of IV bisphosphonates, including zoledronate, in the year prior to the study. Use of denosumab, teriparatide, or any anabolic bone drug within the past 12 months. Use of systemic glucocorticoids (equivalent to more than 5 mg\u002Fday of prednisone) for over 2 weeks in the past 6 months. Use of active vitamin D, strontium ranelate, or other investigational bone health agents in the past 3 months.\n\nChronic Diseases: Diseases affecting bone metabolism or physical mobility, such as uncontrolled thyroid disease, uncontrolled diabetes, or severe gastrointestinal disorders that affect nutrient absorption. Any conditions that cause persistent tremors that might interfere with imaging or medication adherence.\n\nPrevious Participation in Other Studies: Recent participation in clinical trials involving investigational drugs or supplements for bone health within the past 12 months.\n\nAlcohol and Drug Use: Heavy alcohol consumption (\\>2 drinks\u002Fday) or substance abuse that could affect study compliance and bone health.\n\nAllergies and Sensitivities: Known allergies or sensitivities to boron supplements, calcium, vitamin D, or other components of the study drugs.\n\n\\-",true,"FEMALE","45 Years","85 Years",{"count":46,"type":47},30,"ESTIMATED","INTERVENTIONAL",[50],"PHASE2","This study aims to evaluate the impact of boron supplementation (OsteoBor) on bone health in postmenopausal women. The trial is a phase 2, randomised, double-blind, placebo-controlled study lasting one year",[53],"Osteoporosis, Postmenopausal","NOT_YET_RECRUITING","2025-01-30",{"date":57,"type":58},"2025-02-05","ACTUAL",{"date":60,"type":47},"2025-03-01",{"date":62,"type":47},"2025-09-01",{"name":5,"class":6}]