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RECRUITINGPhase 4INTERVENTIONAL

Bone, Exercise, Alendronate, and Caloric Restriction

The Bone, Exercise, Alendronate, and Caloric Restriction Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Community-dwelling - 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)) Who Should NOT Join This Trial: - 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 \<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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Community-dwelling * 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: * 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 \<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

Treatments Being Tested

DRUG

Bisphosphonate

Medicine used to treat bone problems, called osteopenia or osteoporosis.

BEHAVIORAL

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.

OTHER

Placebo

Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.

Locations (2)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States