Bone, Exercise, Alendronate, and Caloric Restriction

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Bone Loss

In brief

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.

Key facts

Study ID

NCT05764733

Run by

Wake Forest University Health Sciences

People needed

900

Starts

2023-06-08

Expected to finish

2028-01-01

Last updated by the study team

2026-06-09

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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