[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05764733":3,"trial-entities:NCT05764733":152,"trial-summary:NCT05764733":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":52,"secondary_outcomes":57,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":104,"locations":107,"central_contacts":142,"overall_officials":144,"references":146,"see_also_links":151},"NCT05764733","IRB00077185","Bone, Exercise, Alendronate, and Caloric Restriction","The Bone, Exercise, Alendronate, and Caloric Restriction Trial","RECRUITING","2028-01","2025-12","2026-06-09","2023-06-08","Wake Forest University Health Sciences","OTHER",true,"The purpose of this research is to identify strategies that minimize bone loss that occurs when older adults lose weight. Participation in this research will involve up to nine assessment visits and last up to two years.","The main objective of this study is to compare the independent and combined effects of a 12-month intervention of resistance training (RT) plus bone-loading exercises and bisphosphonate use on dietary weight loss (WL)-associated bone loss among older adults, with an indication for WL, and low bone density to explore lasting treatment efficacy. All participants will receive the same group-mediated dietary WL intervention and be randomized to one of four groups. Due to its robust change following dietary WL and clinical utility in predicting fracture, the study's primary outcome is change in total hip areal bone mineral density (aBMD) measured via dual x-ray absorptiometry (DXA). This will be complemented by DXA assessment at other skeletal sites, as well as high resolution peripheral quantitative computed tomography (HR-pQCT) derived compartmental volumetric (v)BMD, trabecular bone microarchitecture, cortical thickness\u002Fporosity, and strength at the distal radius and tibia allowing for assessment of intervention effectiveness on novel measures of bone quality.",[19],"Bone Loss",[21,22,23,24,25],"Older Adults","Weight Loss","Resistance Training","Osteoporosis","Osteopenia","INTERVENTIONAL","PREVENTION",[29],"PHASE4",{"count":31,"type":32},900,"ESTIMATED",[34,41,47],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Bisphosphonate","Medicine used to treat bone problems, called osteopenia or osteoporosis.",[39,40],"No RT + BIS","Resistance Training (RT) + Bisphosphonate (BIS)",{"type":42,"name":43,"description":44,"armGroupLabels":45},"BEHAVIORAL","Resistance Training\u002FBone-Loading Exercise","Exercise in small groups three days per week under the supervision of exercise physiologists. Heart rate and blood pressure will be measured before and after each session and participants will warm-up by walking or cycling for five minutes at a slow pace. All RT exercises will be conducted on machines which accommodate different body sizes and allow small increments in resistance, both important considerations for low functioning older adults with obesity.",[46,40],"RT + PL",{"type":14,"name":48,"description":49,"armGroupLabels":50},"Placebo","Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.",[51,46],"No RT + Placebo (PL)",[53],{"measure":54,"description":55,"timeFrame":56},"Change in total hip areal bone mineral density (aBMD)","Dual X-ray absorptiometry (DXA) derived","from baseline through month 12",[58,62,64,68,71,74],{"measure":59,"description":60,"timeFrame":61},"aBMD assessment of the femoral neck","DXA derived","baseline, month 6, month 12",{"measure":63,"description":60,"timeFrame":61},"aBMD assessment of the lumbar spine",{"measure":65,"description":66,"timeFrame":67},"Tibial Trabecular (Tb) BMD","HR-pQCT acquired; Average volumetric BMD \\[mg\u002Fcm3\\]","baseline and month 12",{"measure":69,"description":70,"timeFrame":61},"Tibial Cortical (Ct.) BMD","HR-pQCT acquired; Avg. volumetric BMD \\[mg\u002Fcm3\\]",{"measure":72,"description":73,"timeFrame":67},"Tibial Trabecular Number (Tb.N)","Average number trabeculae per unit length",{"measure":75,"description":76,"timeFrame":67},"Tibial Cortical Thickness (Ct.Th)","Average thickness of cortical compartment in mm","ALL","60 Years",null,false,{"inclusion":82,"exclusion":87,"raw_text":103},[83,84,85,86],"Community-dwelling","BMI\\>30 kg\u002Fm\\^2 or BMI 25.0 to \\\u003C30 kg\u002Fm\\^2 plus one risk factor","Currently receiving routine (annual) dental care","Pre-existing low bone mass (T-score ≤-1.1 to \\>-2.5 at the hip, femoral neck, or lumbar spine (L1-L4))",[88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"Weight greater than 450 lbs (DXA limit)","Resides with someone who is currently participating in BEACON","Dependent on quad cane or walker; inability to walk independently","History of mild cognitive impairment or dementia or evidence of cognitive impairment ((score \\\u003C20) on Montreal Cognitive Assessment (MoCA))","Excessive alcohol use (\\>21 drinks\u002Fweek) in the past month; any non-cannabis illicit drug use","Weight change ≥5% in past 3 months","Regular participation (\\>60 mins per day on \\> 3 days\u002Fweek) in structured strength training program for \\>6 months","Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents safe exercise participation; joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months; invasive dental procedure (i.e. extraction\u002Fimplant) in past 6 month or planned in next 12 months","Osteoporosis (any of the following): Self-reported and on prescription osteoporosis medication; self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height), including atypical femoral fractures (AFF); or ≥20% for major osteoporotic fracture at screening","Uncontrolled hypertension (systolic \\>180 OR diastolic \\>110 mmHg) upon repeated assessments (up to 3 times)","Uncontrolled type 2 diabetes (HbA1c \\>8%); dialysis or abnormal kidney function (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2); liver disease or abnormal liver function (ALT levels 2 times above normal); anemia (Hb\\\u003CLLN); calcium above or below normal limit; uncontrolled thyroid disease (hypo\u002Fhyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or thyroid-stimulating hormone \\\u003CLLN or \\>10 mIU\u002Fml; vitamin D deficiency (\\\u003C20 ng\u002FmL).","Stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past 6 months; chronic respiratory disease requiring oxygen; PAD diagnosis within the last 12 months; uncontrolled angina; progressive neurological disease; malabsorption disorder; any disease suggesting a life-expectancy \\\u003C3 years; bilateral hip replacement; past or planned bariatric surgery; cancer requiring initial treatment within the last 12 months (except non-melanoma skin cancers); major vision or hearing loss; unstable gastric reflux; esophageal stricture, achalasia, or Barrett's esophagus","Daily use of growth hormones, weight loss medications, oral steroids, or diabetes prescriptions (such as insulin, thiazolidinediones, or canagliflozin); known allergy to bisphosphonates; prior use of oral bisphosphonates for \\>3 months within the past 3 years; zoledronic acid within the past 5 years; denosumab use within the past year; anabolic agents for \\>3 months in the last year; current use of biotin or strontium; history of 3+ years of antiresorptive therapy","Unable\u002Funwilling to: provide own transportation to study visits, commit to study protocol (including random assignment), or adhere to data collection visits","Current participation in another intervention research study; planned out-of-town trip greater than 1 month at a time during the first 6 months of the study; unwilling to provide informed consent, including consent to access personal electronic health records; judged unsuitable for the trial for any reason by research team","Inclusion Criteria:\n\n* Community-dwelling\n* BMI\\>30 kg\u002Fm\\^2 or BMI 25.0 to \\\u003C30 kg\u002Fm\\^2 plus one risk factor\n* Currently receiving routine (annual) dental care\n* Pre-existing low bone mass (T-score ≤-1.1 to \\>-2.5 at the hip, femoral neck, or lumbar spine (L1-L4))\n\nExclusion Criteria:\n\n* Weight greater than 450 lbs (DXA limit)\n* Resides with someone who is currently participating in BEACON\n* Dependent on quad cane or walker; inability to walk independently\n* History of mild cognitive impairment or dementia or evidence of cognitive impairment ((score \\\u003C20) on Montreal Cognitive Assessment (MoCA))\n* Excessive alcohol use (\\>21 drinks\u002Fweek) in the past month; any non-cannabis illicit drug use\n* Weight change ≥5% in past 3 months\n* Regular participation (\\>60 mins per day on \\> 3 days\u002Fweek) in structured strength training program for \\>6 months\n* Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents safe exercise participation; joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months; invasive dental procedure (i.e. extraction\u002Fimplant) in past 6 month or planned in next 12 months\n* Osteoporosis (any of the following): Self-reported and on prescription osteoporosis medication; self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height), including atypical femoral fractures (AFF); or ≥20% for major osteoporotic fracture at screening\n* Uncontrolled hypertension (systolic \\>180 OR diastolic \\>110 mmHg) upon repeated assessments (up to 3 times)\n* Uncontrolled type 2 diabetes (HbA1c \\>8%); dialysis or abnormal kidney function (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2); liver disease or abnormal liver function (ALT levels 2 times above normal); anemia (Hb\\\u003CLLN); calcium above or below normal limit; uncontrolled thyroid disease (hypo\u002Fhyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or thyroid-stimulating hormone \\\u003CLLN or \\>10 mIU\u002Fml; vitamin D deficiency (\\\u003C20 ng\u002FmL).\n* Stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past 6 months; chronic respiratory disease requiring oxygen; PAD diagnosis within the last 12 months; uncontrolled angina; progressive neurological disease; malabsorption disorder; any disease suggesting a life-expectancy \\\u003C3 years; bilateral hip replacement; past or planned bariatric surgery; cancer requiring initial treatment within the last 12 months (except non-melanoma skin cancers); major vision or hearing loss; unstable gastric reflux; esophageal stricture, achalasia, or Barrett's esophagus\n* Daily use of growth hormones, weight loss medications, oral steroids, or diabetes prescriptions (such as insulin, thiazolidinediones, or canagliflozin); known allergy to bisphosphonates; prior use of oral bisphosphonates for \\>3 months within the past 3 years; zoledronic acid within the past 5 years; denosumab use within the past year; anabolic agents for \\>3 months in the last year; current use of biotin or strontium; history of 3+ years of antiresorptive therapy\n* Unable\u002Funwilling to: provide own transportation to study visits, commit to study protocol (including random assignment), or adhere to data collection visits\n* Current participation in another intervention research study; planned out-of-town trip greater than 1 month at a time during the first 6 months of the study; unwilling to provide informed consent, including consent to access personal electronic health records; judged unsuitable for the trial for any reason by research team",[105,106],"ADULT","OLDER_ADULT",[108,124],{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":121},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States",[115,119],{"name":116,"role":117,"email":118},"Sarah Wherry, PhD","CONTACT","sarah.wherry@cuanschutz.edu",{"name":116,"role":120},"PRINCIPAL_INVESTIGATOR",{"lat":122,"lon":123},39.72943,-104.83192,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":113,"contacts":129,"geoPoint":139},"Atrium Health Wake Forest Baptist Medical Center","Winston-Salem","North Carolina","27157",[130,134,138],{"name":131,"role":117,"phone":132,"email":133},"Kristen Beavers, PhD","336-758-5855","kristen.beavers@wfusm.edu",{"name":135,"role":117,"phone":136,"email":137},"Christa Todoroff Calderone, M.S.","336-758-5019","todorocm@wfu.edu",{"name":131,"role":120},{"lat":140,"lon":141},36.09986,-80.24422,[143],{"name":135,"role":117,"phone":136,"email":137},[145],{"name":131,"affiliation":13,"role":120},[147],{"pmid":148,"type":149,"citation":150},"39293778","BACKGROUND","Beavers KM, Wolle BR, Ard JD, Beavers DP, Biehl O, Brubaker PH, Burghardt AJ, Calderone CT, Carballido-Gamio J, Fanning J, Kohrt WM, Love M, MacLean CM, Nicklas BJ, Stapleton J, Swanson CM, Weaver AA, Worden M, Wherry SJ. The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods. Contemp Clin Trials. 2024 Nov;146:107692. doi: 10.1016\u002Fj.cct.2024.107692. Epub 2024 Sep 17.",[],{"nct_id":4,"conditions":153,"biomarkers":154},[25],[],{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This interventional study plans to enroll 900 participants who will be randomized into one of four groups. It is not specified if the study is blinded.","completed","Bone, Exercise, Alendronate, and Caloric Restriction Study","This study is looking for strategies to reduce bone loss when older adults lose weight. It is testing the effects of a medicine called alendronate (a bisphosphonate, used to treat bone problems like osteopenia or osteoporosis) and resistance training\u002Fbone-loading exercises. You might be able to join if you are 60 or older, live in the community, have a BMI over 30 or a BMI between 25 and 30 with an additional risk factor, receive regular dental care, and have low bone mass. The main goal is to see how these interventions affect your total hip bone mineral density (a measure of bone strength) over 12 months. The study status is currently unclear.","The primary outcome, change in total hip bone mineral density, is measured from baseline through month 12.",112,"Participation involves up to nine assessment visits and lasts up to two years. You will receive a dietary weight loss intervention and, depending on your group, either alendronate, a placebo, or resistance training\u002Fbone-loading exercises three days a week.","Not stated in the trial record.",[36,43],"v2"]