Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
900 participants
INTERVENTIONAL
2023-06-08
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Resistance Training (RT) + Bisphosphonate (BIS)
Progressive Resistance Training (RT) and Bone-Loading Exercise
\+ 70 mg/weekly dose alendronate
Bisphosphonate
Medicine used to treat bone problems, called osteopenia or osteoporosis.
Resistance Training/Bone-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.
No RT + BIS
No Resistance Training
\+ 70 mg/weekly dose alendronate
Bisphosphonate
Medicine used to treat bone problems, called osteopenia or osteoporosis.
No RT + Placebo (PL)
No Resistance Training + Weekly Placebo
Placebo
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.
RT + PL
Progressive RT and Bone-Loading Exercise + Weekly Placebo
Resistance Training/Bone-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.
Placebo
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.
Interventions
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Bisphosphonate
Medicine used to treat bone problems, called osteopenia or osteoporosis.
Resistance Training/Bone-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.
Placebo
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.
Eligibility Criteria
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Inclusion Criteria
* BMI\>30 kg/m\^2 or BMI 25.0 to \<30 kg/m\^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))
Exclusion Criteria
* 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 \<20) on Montreal Cognitive Assessment (MoCA))
* Excessive alcohol use (\>21 drinks/week) 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/week) 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/implant) 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 \<45 mL/min/1.73 m2); liver disease or abnormal liver function (ALT levels 2 times above normal); anemia (Hb\<LLN); calcium above or below normal limit; uncontrolled thyroid disease (hypo/hyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or thyroid-stimulating hormone \<LLN or \>10 mIU/ml; vitamin D deficiency (\<20 ng/mL).
* 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 \<3 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/unwilling 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
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Kristen Beavers, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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/j.cct.2024.107692. Epub 2024 Sep 17.
Other Identifiers
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IRB00077185
Identifier Type: -
Identifier Source: org_study_id