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NCT05764733RecruitingPhase 4

Bone, Exercise, Alendronate, and Caloric Restriction

The Bone, Exercise, Alendronate, and Caloric Restriction Trial

Source: ClinicalTrials.gov · Last updated 9 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
900 (estimated)
First submitted
23 Feb 2023
Start date
8 Jun 2023
Primary completion date
Jan 2028
Lead sponsor
Wake Forest University Health Sciences
Diseases
Osteoporosis
NCT number
NCT05764733

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 900
  • From 8 Jun 2023 to the primary completion date, Jan 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Excessive alcohol use (\>21 drinks/week) in the past month; any non-cannabis illicit drug use
  • 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
  • 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

Other illness

  • History of mild cognitive impairment or dementia or evidence of cognitive impairment ((score \<20) on Montreal Cognitive Assessment (MoCA))
  • 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
  • Uncontrolled hypertension (systolic \>180 OR diastolic \>110 mmHg) upon repeated assessments (up to 3 times)

Lab values

  • 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).

Age

  • 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

Other

  • 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
  • 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
  • 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

Who the study is looking for

  • 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))

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Anschutz Medical Campus
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Atrium Health Wake Forest Baptist Medical Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.