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Bone LossPhase 4BEACONNCT05764733

Bone, Exercise, Alendronate, and Caloric Restriction

A Phase 4 study testing Bisphosphonate and Resistance Training/Bone-Loading Exercise in people with Bone Loss, run by Wake Forest University Health Sciences at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Bone Loss
What is being tested?
Bisphosphonate and Resistance Training/Bone-Loading Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
2 sitesUnited States
Study dates
8 Jun 2023to Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christa Todoroff Calderone, M.S. contact

336-758-5019

todorocm@wfu.edu

United States2 sites, 2 recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Sarah Wherry, PhD, sarah.wherry@cuanschutz.edu

    Sarah Wherry, PhD

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Kristen Beavers, PhD, 336-758-5855, kristen.beavers@wfusm.edu

    Christa Todoroff Calderone, M.S., 336-758-5019, todorocm@wfu.edu

    Recruiting

Other trials in United States

About this study

Official title: The Bone, Exercise, Alendronate, and Caloric Restriction 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.

Read the detailed description

The main objective of this study is to compare the independent and combined effects of a 12-month intervention of resistance training (RT) plus bone-loading exercises and bisphosphonate use on dietary weight loss (WL)-associated bone loss among older adults, with an indication for WL, and low bone density to explore lasting treatment efficacy. All participants will receive the same group-mediated dietary WL intervention and be randomized to one of four groups. Due to its robust change following dietary WL and clinical utility in predicting fracture, the study's primary outcome is change in total hip areal bone mineral density (aBMD) measured via dual x-ray absorptiometry (DXA). This will be complemented by DXA assessment at other skeletal sites, as well as high resolution peripheral quantitative computed tomography (HR-pQCT) derived compartmental volumetric (v)BMD, trabecular bone microarchitecture, cortical thickness/porosity, and strength at the distal radius and tibia allowing for assessment of intervention effectiveness on novel measures of bone quality.

Conditions
Bone Loss
Being tested
Bisphosphonate, Resistance Training/Bone-Loading Exercise, Placebo
Keywords
Older Adults, Weight Loss, Resistance Training, Osteoporosis, Osteopenia
Medical subject headings
Bone Diseases, Metabolic, Weight Loss, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BisphosphonateDrug

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

  • Resistance Training/Bone-Loading ExerciseBehavioural

    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.

  • PlaceboOther

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

Study groups in NCT05764733
Study groupRoleWhat they receive
Resistance Training (RT) + Bisphosphonate (BIS)ExperimentalProgressive Resistance Training (RT) and Bone-Loading Exercise + 70 mg/weekly dose alendronate
Receives: Drug: Bisphosphonate; Behavioral: Resistance Training/Bone-Loading Exercise
No RT + BISExperimentalNo Resistance Training + 70 mg/weekly dose alendronate
Receives: Drug: Bisphosphonate
No RT + Placebo (PL)Active comparatorNo Resistance Training + Weekly Placebo
Receives: Other: Placebo
RT + PLActive comparatorProgressive RT and Bone-Loading Exercise + Weekly Placebo
Receives: Behavioral: Resistance Training/Bone-Loading Exercise; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total hip areal bone mineral density (aBMD)

    Dual X-ray absorptiometry (DXA) derived

    Measured: from baseline through month 12

Secondary outcomes (6)

  1. aBMD assessment of the femoral neck

    DXA derived

    Measured: baseline, month 6, month 12

  2. aBMD assessment of the lumbar spine

    DXA derived

    Measured: baseline, month 6, month 12

  3. Tibial Trabecular (Tb) BMD

    HR-pQCT acquired; Average volumetric BMD [mg/cm3]

    Measured: baseline and month 12

  4. Tibial Cortical (Ct.) BMD

    HR-pQCT acquired; Avg. volumetric BMD [mg/cm3]

    Measured: baseline, month 6, month 12

  5. Tibial Trabecular Number (Tb.N)

    Average number trabeculae per unit length

    Measured: baseline and month 12

  6. Tibial Cortical Thickness (Ct.Th)

    Average thickness of cortical compartment in mm

    Measured: baseline and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start8 Jun 2023
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
This is a 2x2 factorial design.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764733
Sponsor's protocol ID
IRB00077185
Other IDs
R01AG074979
Acronym
BEACON
Status last verified
Dec 2025
First submitted
23 Feb 2023
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beavers KM, Wolle BR, Ard JD, Beavers DP, Biehl O, Brubaker PH, Burghardt AJ, Calderone CT, Carballido-Gamio J, Fanning J, Kohrt WM, Love M, MacLean CM, Nicklas BJ, Stapleton J, Swanson CM, Weaver AA, Worden M, Wherry SJ. The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods. Contemp Clin Trials. 2024 Nov;146:107692. doi: 10.1016/j.cct.2024.107692. Epub 2024 Sep 17.

    PubMed 39293778

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bisphosphonate and Resistance Training/Bone-Loading Exercise in people with Bone Loss, run by Wake Forest University Health Sciences at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christa Todoroff Calderone, M.S. (336-758-5019, todorocm@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total hip areal bone mineral density (aBMD) (time frame: from baseline through month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764733, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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