The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods.
Kristen M Beavers, Brianna R Wolle, Jamy D Ard...
https://pubmed.ncbi.nlm.nih.gov/39293778/Actively Recruiting
Led by Wake Forest University Health Sciences · Updated on 2026-06-09
900
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are exploring ways to reduce bone loss that happens when older adults lose weight. This study focuses on older adults with low bone density who are advised to lose weight, aiming to compare the effects of resistance training combined with bone-loading exercises and a medication called bisphosphonate. The goal is to understand which strategies best protect bone health during weight loss over a 12-month period. Participants are randomly assigned to one of four groups resistance training plus weekly bisphosphonate, bisphosphonate alone, resistance training plus a placebo, or placebo alone. All participants follow the same dietary weight loss program. Resistance training involves supervised exercise sessions three times a week using machines suitable for older adults. The medication is given weekly, and placebo capsules match the medication in appearance and schedule. Participants will attend up to nine assessment visits over two years. Bone density and quality will be measured using dual x-ray absorptiometry and high-resolution CT scans at various skeletal sites including the hip, femoral neck, lumbar spine, radius, and tibia. Researchers will track changes in bone mineral density and microarchitecture to evaluate treatment effects. Safety and adherence will be monitored throughout the study, which is expected to complete by early 2028.
CONDITIONS
Bone, Exercise, Alendronate, and Caloric Restriction
C
Christa Todoroff Calderone, M.S.
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Wake Forest University Health Sciences
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | RT + Bisphosphonate | Bisphosphonate only | Resistance Training only | Placebo | Standard Bisphosphonate + Lifestyle Advice |
|---|---|---|---|---|---|
| What it is | Combined resistance training plus bisphosphonate intervention as tested in the trial | Bisphosphonate alone intervention arm | Resistance training alone intervention arm | Placebo control arm | Typical preventive approach using oral bisphosphonate combined with lifestyle advice (exercise, diet) |
| Role in the study | Investigational combined intervention arm | Isolates drug effect | Isolates exercise effect | Control for both interventions | Reflects usual prevention practice |
| Primary use | Prevent bone loss during weight loss in older adults with low bone mass | Drug-only prevention of bone loss in same population | Exercise-only prevention of bone loss in same population | Baseline comparison during weight loss | Standard prevention of fracture risk using bisphosphonates and exercise advice |
| Administration or performance | Supervised resistance training three times weekly plus oral bisphosphonate capsules | Oral bisphosphonate capsules with dosing and follow up as per protocol | Supervised resistance training sessions three times weekly | Placebo capsules matching dosing schedule of bisphosphonate group | Oral bisphosphonate per usual schedule plus general lifestyle advice on exercise and diet |
| Evidence status | Efficacy under study; results pending | Established ability to increase bone density and reduce fractures | Exercise associated with smaller and less consistent bone density gains | No active treatment; serves as control | Bisphosphonates reduce fracture risk; exercise adds modest benefit |
| Important risks | Risks include bisphosphonate adverse effects; exercise safety monitored | Possible rare risks (jaw osteonecrosis, atypical femoral fracture) with long use | Potential musculoskeletal injury risk during exercise | No active treatment risk | Known bisphosphonate rare risks plus low-risk lifestyle advice |
| Limitations | Unknown; trial results not yet available | Does not assess combined effect with exercise | Exercise benefit may be modest compared to pharmacologic effect | Does not provide active prevention | Evidence mostly from populations with osteoporosis, not overweight/obese older adults losing weight |
| Patient impact | Unknown until trial completes | Reduction in fracture risk established in broader populations | Potential modest improvement in bone strength and fall reduction | No expected protective effect | Reduces fracture risk with added modest benefit from lifestyle changes |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants follow a dietary weight loss program and are randomly assigned to one of four groups involving resistance training, bisphosphonate medication, or placebo.
Up to nine assessment visits over two years
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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Kristen M Beavers, Brianna R Wolle, Jamy D Ard...
https://pubmed.ncbi.nlm.nih.gov/39293778/Wake Forest University Health Sciences
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor