- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764733
Bone, Exercise, Alendronate, and Caloric Restriction (BEACON)
February 27, 2024 updated by: Wake Forest University Health Sciences
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
700
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kristen Beavers, PhD
- Phone Number: 336-758-5855
- Email: beaverkm@wfu.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Anschutz Medical Campus
-
Contact:
- Sarah Wherry, PhD
- Email: sarah.wherry@cuanschutz.edu
-
Principal Investigator:
- Sarah Wherry, PhD
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Atrium Health Wake Forest Baptist
-
Contact:
- Kristen Beavers, PhD
- Phone Number: 336-758-5855
- Email: beaverkm@wfu.edu
-
Principal Investigator:
- Kristen Beavers, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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))
Exclusion Criteria:
- 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); FRAX 10-year risk scores ≥3% for hip fracture 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistance Training (RT) + Bisphosphonate (BIS)
Progressive Resistance Training (RT) and Bone-Loading Exercise + 70 mg/weekly dose alendronate |
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.
Medicine used to treat bone problems, called osteopenia or osteoporosis.
|
Experimental: No RT + BIS
No Resistance Training + 70 mg/weekly dose alendronate |
Medicine used to treat bone problems, called osteopenia or osteoporosis.
|
Active Comparator: No RT + Placebo (PL)
No Resistance Training + Weekly Placebo
|
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.
|
Active Comparator: RT + PL
Progressive RT and Bone-Loading Exercise + Weekly Placebo
|
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.
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total hip areal bone mineral density (aBMD)
Time Frame: from baseline through month 12
|
Dual X-ray absorptiometry (DXA) derived
|
from baseline through month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aBMD assessment of the femoral neck
Time Frame: baseline, month 6, month 12
|
DXA derived
|
baseline, month 6, month 12
|
aBMD assessment of the lumbar spine
Time Frame: baseline, month 6, month 12
|
DXA derived
|
baseline, month 6, month 12
|
Tibial Trabecular (Tb) BMD
Time Frame: baseline and month 12
|
HR-pQCT acquired; Average volumetric BMD [mg/cm3]
|
baseline and month 12
|
Tibial Cortical (Ct.) BMD
Time Frame: baseline, month 6, month 12
|
HR-pQCT acquired; Avg.
volumetric BMD [mg/cm3]
|
baseline, month 6, month 12
|
Tibial Trabecular Number (Tb.N)
Time Frame: baseline and month 12
|
Average number trabeculae per unit length
|
baseline and month 12
|
Tibial Cortical Thickness (Ct.Th)
Time Frame: baseline and month 12
|
Average thickness of cortical compartment in mm
|
baseline and month 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tibial Total bone mineral density (Tt.BMD)
Time Frame: baseline and month 12
|
High resolution peripheral quantitative computed tomography (HR-pQCT) acquired; Avg.
volumetric BMD [mg/cm3]
|
baseline and month 12
|
Tibial Total Area (Tt.Ar)
Time Frame: baseline and month 12
|
HR-pQCT acquired; Avg.
cross-sectional area (all slices)
|
baseline and month 12
|
Tibial Trabecular Area (Tb Ar)
Time Frame: baseline and month 12
|
HR-pQCT acquired; Avg.
cross-sectional area (all slices)
|
baseline and month 12
|
Tibial Cortical Area (Ct.Ar)
Time Frame: baseline and month 12
|
HR-pQCT acquired; Avg.
cross-sectional area (all slices)
|
baseline and month 12
|
Tibial Total Trabecular Volume (Tt.TV)
Time Frame: baseline and month 12
|
total Volume in tissue compartments; millimeter (mm)^3
|
baseline and month 12
|
Tibial Trabecular Volume (Tb.TV)
Time Frame: baseline and month 12
|
Volumes in trabecular compartments; mm^3
|
baseline and month 12
|
Tibial Cortical Volume (Ct.TV)
Time Frame: baseline and month 12
|
Volumes in cortical compartments; mm^3
|
baseline and month 12
|
Tibial Cortical Perimeter (Ct.Pm)
Time Frame: baseline and month 12
|
millimeter; Average periosteal perimeter (all slices)
|
baseline and month 12
|
Tibial Trabecular Bone Volume Fraction (Tb.BV/TV)
Time Frame: baseline and month 12
|
Volume ratio of bone in trabecular compartment percentage
|
baseline and month 12
|
Tibial Trabecular Thickness (Tb.Th)
Time Frame: baseline and month 12
|
Average thickness of trabeculae in mm
|
baseline and month 12
|
Tibial Trabecular Separation (Tb.Sp)
Time Frame: baseline and month 12
|
Avg distance between trabeculae in mm
|
baseline and month 12
|
Tibial Inhomogeneity of Trabecular Network
Time Frame: baseline and month 12
|
Volume ratio of pores in cortical compartment
|
baseline and month 12
|
Tibial Cortical Porosity (Ct.Po)
Time Frame: baseline and month 12
|
Volume ratio of pores in cortical compartment
|
baseline and month 12
|
Tibial Cortical Pore Diameter (Ct.Po.Dm)
Time Frame: baseline and month 12
|
Average 3D diameter of pore volumes
|
baseline and month 12
|
Tibial Cortical Pore Volume (Ct.Po.V)
Time Frame: baseline and month 12
|
Total volume of cortical pores
|
baseline and month 12
|
Tibial Estimated Failure Load (FL)
Time Frame: baseline and month 12
|
Estimated by calculation of the reaction force at which 7.5% of the elements exceed a local effective strain of 0.7%
|
baseline and month 12
|
Tibial Bone Stiffness
Time Frame: baseline and month 12
|
Reaction force divided by displacement
|
baseline and month 12
|
Bone Formation Assay
Time Frame: baseline, month 6, month 12
|
Procollagen type I N-propeptide (PINP) is a biomarker of bone formation (mcg/L)
|
baseline, month 6, month 12
|
Bone Resorption Assay
Time Frame: baseline, month 6, month 12
|
C-terminal telopeptide of type I collagen (CTX) is a biomarker of bone resorption (pg/mL)
|
baseline, month 6, month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kristen Beavers, PhD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
February 23, 2023
First Submitted That Met QC Criteria
March 7, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00077185
- R01AG074979 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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