NCT05764733 · Wake Forest University Health Sciences
Bone, Exercise, Alendronate, and Caloric Restriction
(BEACON)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Change in total hip areal bone mineral density (aBMD)
Time frame: from baseline through month 12
Dual X-ray absorptiometry (DXA) derived
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 oth
Where
- Aurora, Colorado
- Winston-Salem, North Carolina
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations