NCT05764733

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_4

Timeline
17mo left

Started Jun 2023

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2023Sep 2027

First Submitted

Initial submission to the registry

February 23, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4.2 years

First QC Date

February 23, 2023

Last Update Submit

December 11, 2025

Conditions

Bone Loss

Keywords

Older AdultsWeight LossResistance TrainingOsteoporosisOsteopenia

Outcome Measures

Primary Outcomes (1)

  • Change in total hip areal bone mineral density (aBMD)

    Dual X-ray absorptiometry (DXA) derived

    from baseline through month 12

Secondary Outcomes (6)

  • aBMD assessment of the femoral neck

    baseline, month 6, month 12

  • aBMD assessment of the lumbar spine

    baseline, month 6, month 12

  • Tibial Trabecular (Tb) BMD

    baseline and month 12

  • Tibial Cortical (Ct.) BMD

    baseline, month 6, month 12

  • Tibial Trabecular Number (Tb.N)

    baseline and month 12

  • +1 more secondary outcomes

Other Outcomes (19)

  • Tibial Total bone mineral density (Tt.BMD)

    baseline and month 12

  • Tibial Total Area (Tt.Ar)

    baseline and month 12

  • Tibial Trabecular Area (Tb Ar)

    baseline and month 12

  • +16 more other outcomes

Study Arms (4)

Resistance Training (RT) + Bisphosphonate (BIS)

EXPERIMENTAL

Progressive Resistance Training (RT) and Bone-Loading Exercise \+ 70 mg/weekly dose alendronate

Drug: BisphosphonateBehavioral: Resistance Training/Bone-Loading Exercise

No RT + BIS

EXPERIMENTAL

No Resistance Training \+ 70 mg/weekly dose alendronate

Drug: Bisphosphonate

No RT + Placebo (PL)

ACTIVE COMPARATOR

No Resistance Training + Weekly Placebo

Other: Placebo

RT + PL

ACTIVE COMPARATOR

Progressive RT and Bone-Loading Exercise + Weekly Placebo

Behavioral: Resistance Training/Bone-Loading ExerciseOther: Placebo

Interventions

BisphosphonateDRUG

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

No RT + BISResistance Training (RT) + Bisphosphonate (BIS)
Resistance Training/Bone-Loading ExerciseBEHAVIORAL

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.

RT + PLResistance Training (RT) + Bisphosphonate (BIS)
PlaceboOTHER

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

No RT + Placebo (PL)RT + PL

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39293778BACKGROUND

MeSH Terms

Conditions

Bone Diseases, MetabolicWeight LossOsteoporosis

Interventions

Diphosphonates

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Kristen Beavers, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christa Todoroff Calderone, M.S.

CONTACT

336-758-5019todorocm@wfu.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking applies to drug only. All assessments will be conducted by trained and blinded assessors.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: This is a 2x2 factorial design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 13, 2023

Study Start

June 8, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)