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/39293778Actively Recruiting
Phase 4
Age: 60Years +
All Genders
ID05764733
The Bone, Exercise, Alendronate, and Caloric Restriction Trial to Study Bone Loss in Older Adults
Led by Wake Forest University Health Sciences · Updated on 2025-12-17
900
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on older adults who are losing weight and experiencing bone loss. It aims to find strategies that reduce bone loss linked to weight loss in people with low bone density. The study is a phase 4 clinical trial comparing the effects of resistance training combined with bone-loading exercises and a medication called bisphosphonate on bone health. Participants will all follow a dietary weight loss program and be randomly assigned to one of four groups: resistance training plus bisphosphonate, bisphosphonate alone, placebo alone, or resistance training plus placebo. Resistance training involves supervised exercise sessions three times weekly using machines designed for older adults. Bisphosphonate is taken as a weekly 70 mg dose, and placebo capsules look identical but contain no active drug. Participants will attend up to nine assessment visits over two years. Researchers will measure bone density and quality using scans such as dual x-ray absorptiometry (DXA) at various bone sites including the hip, femoral neck, lumbar spine, radius, and tibia. Other assessments include detailed bone structure and strength evaluations. The main outcome is the change in bone density at the hip after 12 months. Safety and treatment effects will be closely monitored throughout the study.
CONDITIONS
Brief Title
Bone, Exercise, Alendronate, and Caloric Restriction
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Community-dwelling adults
- Body mass index (BMI) over 30 kg/m2 or BMI 25 to less than 30 kg/m2 with one risk factor
- Currently receiving routine annual dental care
- Low bone mass with T-score between -1.1 and -2.5 at the hip, femoral neck, or lumbar spine (L1-L4)
You will not qualify if you...
- Weight over 450 pounds
- Living with someone currently participating in this study
- Dependence on quad cane or walker; inability to walk independently
- History or evidence of cognitive impairment (MoCA score below 20)
- Excessive alcohol use (more than 21 drinks per week) in past month or illicit drug use
- Weight change of 5% or more in past 3 months
- Regular strength training over 60 minutes per day on more than 3 days per week for over 6 months
- Severe arthritis, recent or planned joint surgery, or musculoskeletal disorders preventing safe exercise
- Osteoporosis with prior fractures or high fracture risk
- Uncontrolled high blood pressure or diabetes, kidney or liver disease, anemia, abnormal calcium or thyroid levels, or vitamin D deficiency
- Recent heart or respiratory conditions, neurological disease, malabsorption, limited life expectancy, bilateral hip replacement, bariatric surgery, recent cancer treatment, major vision or hearing loss, or unstable digestive issues
- Use of certain medications like growth hormones, weight loss drugs, steroids, or diabetes drugs
- Allergy to bisphosphonates or recent use of similar bone medications
- Unable or unwilling to provide transportation, follow study protocol, or attend visits
- Participation in another intervention study or long out-of-town trips planned during first 6 months
- Unwilling to give informed consent or judged unsuitable by research team for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive a 12-month intervention including resistance training with bone-loading exercises and/or weekly medication with bisphosphonate or placebo, alongside a group-mediated dietary weight loss program.
Exercise sessions 3 times per week and weekly medication dosing; bone density assessments at baseline, month 6, and month 12
Trial Site Locations
Total: 2 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Loading map...
Research Team
C
Christa Todoroff Calderone, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here