[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629364":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":37,"locations":43,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Tufts Medical Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Veverimer 9 g\u002Fday","EXPERIMENTAL",null,[13],"Drug: veverimer daily",{"label":15,"type":10,"description":11,"interventionNames":16},"Veverimer 9 g\u002Fevery other day",[17],"Drug: veverimer every other day",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide)","PLACEBO_COMPARATOR",[22],"Other: Placebo",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","veverimer daily","8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"veverimer every other day","8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day",[15],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Placebo","8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day",[19],[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Elise Danico, MS","CONTACT","617-636-3232","elise.danico@tuftsmedicine.org",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02111","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,61],{"name":59,"role":40,"phone":60,"phoneExt":11,"email":42},"Elise Danico","617-636-3273",{"name":62,"role":63,"phone":11,"phoneExt":11,"email":11},"Lisa Ceglia, MD MS","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[67],{"name":68,"class":69},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH","100629364","phase-1-veverimer-to-decrease-net-acid-excretion-and-bone-resorption-in-adults-with-osteopenia-100629364",false,"NCT07473713","Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia","Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia: a Dose-finding Randomized Controlled Trial","Inclusion Criteria:\n\n1. Community dwelling adults age 50 years and older (approximately equal numbers of men and women).\n2. Men should be sterile or agree to use contraception throughout the study.\n3. Women must be postmenopausal, defined as no menses in the last 5 years (to reduce variability in change in bone resorption since menopause prompts a rapid increase in bone resorption).\n4. Osteopenia will be defined as a bone mineral density (BMD) T-score at the lumbar spine, femoral neck, or total hip lower than -1 or higher than -2.5.\n5. On a prescreening interview, candidates must report a usual diet associated with an acid load by our validated short questionnaire.\n6. Estimated glomerular filtration rate (eGFR) must be 45 ml\u002Fmin or greater.\n7. Participants must agree not to change their exercise pattern or medication use during the study.\n8. Participants must agree not to change their pattern of supplement use and not to use antacids during the study because most calcium supplements and other antacids add alkali.\n9. Participants must agree to not change their eating habits or intentionally change their weight.\n\nExclusion Criteria:\n\n1. Normal BMD T-scores at all spine and hip sites, osteoporosis based on BMD T-score of -2.5 or less\n2. Respiratory illness in last month\n3. Chronic obstructive pulmonary disease (COPD)\n4. Asthma\n5. Nausea\u002Fvomiting in last month\n6. Dysphagia\n7. Malabsorption\n8. Inflammatory bowel disease\n9. Chronic diarrhea (defined as loose bowel movements daily) or constipation (≤ 2 stools per week)\n10. Insulin-requiring diabetes or fasting plasma glucose \\>125 mg\u002Fdl\n11. Untreated thyroid disease\n12. Cirrhosis\n13. Current unstable heart disease\n14. Malignancy (except non-melanoma skin cancer) or cancer therapy in last year\n15. Alcohol use \\>2 drinks\u002Fday.\n16. Individuals who are unable to provide informed consent due to cognitive impairment.","ALL","50 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","The goal of this clinical trial is to learn if veverimer will reduce urinary net acid excretion leading to reduced bone resorption in healthy adults with osteopenia. The main questions it aims to answer are:\n\n* How much does each dose of veverimer (vs. placebo) reduce 24-hr urinary net acid excretion.\n* Describe the safety of veverimer based on changes in serum bicarbonate and potassium.\n* Assess the changes in bone resorption.\n* Assess the changes in bone formation.\n* Explore the effect of veverimer on physical performance.\n\nParticipants will:\n\n* Take veverimer or placebo every day or every other day for 8 weeks\n* Visit the clinic a total of 8 times (including screening) for checkups and testing\n* Keep a medication diary tracking each day they take the study drug",[87],"Osteopenia",[87,89],"veverimer","2026-03-31",{"date":92,"type":93},"2026-04-06","ACTUAL",{"date":95,"type":81},"2026-04-15",{"date":97,"type":81},"2028-05-01",{"name":5,"class":6},1]