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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG074979 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Training (RT) + Bisphosphonate (BIS) | Experimental | Progressive Resistance Training (RT) and Bone-Loading Exercise + 70 mg/weekly dose alendronate |
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| No RT + BIS | Experimental | No Resistance Training + 70 mg/weekly dose alendronate |
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| No RT + Placebo (PL) | Active Comparator | No Resistance Training + Weekly Placebo |
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| RT + PL | Active Comparator | Progressive RT and Bone-Loading Exercise + Weekly Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisphosphonate | Drug | Medicine used to treat bone problems, called osteopenia or osteoporosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in total hip areal bone mineral density (aBMD) | Dual X-ray absorptiometry (DXA) derived | from baseline through month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| aBMD assessment of the femoral neck | DXA derived | baseline, month 6, month 12 |
| aBMD assessment of the lumbar spine | DXA derived | baseline, month 6, month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Tibial Total bone mineral density (Tt.BMD) | High resolution peripheral quantitative computed tomography (HR-pQCT) acquired; Avg. volumetric BMD [mg/cm3] | baseline and month 12 |
| Tibial Total Area (Tt.Ar) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christa Todoroff Calderone, M.S. | Contact | 336-758-5019 | todorocm@wfu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristen Beavers, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39293778 | Background | 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. |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D015431 | Weight Loss |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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This is a 2x2 factorial design.
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Masking applies to drug only. All assessments will be conducted by trained and blinded assessors.
| Resistance Training/Bone-Loading Exercise | Behavioral | 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. |
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| Placebo | Other | Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group. |
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| Tibial Trabecular (Tb) BMD | HR-pQCT acquired; Average volumetric BMD [mg/cm3] | baseline and month 12 |
| Tibial Cortical (Ct.) BMD | HR-pQCT acquired; Avg. volumetric BMD [mg/cm3] | baseline, month 6, month 12 |
| Tibial Trabecular Number (Tb.N) | Average number trabeculae per unit length | baseline and month 12 |
| Tibial Cortical Thickness (Ct.Th) | Average thickness of cortical compartment in mm | baseline and month 12 |
HR-pQCT acquired; Avg. cross-sectional area (all slices)
| baseline and month 12 |
| Tibial Trabecular Area (Tb Ar) | HR-pQCT acquired; Avg. cross-sectional area (all slices) | baseline and month 12 |
| Tibial Cortical Area (Ct.Ar) | HR-pQCT acquired; Avg. cross-sectional area (all slices) | baseline and month 12 |
| Tibial Total Trabecular Volume (Tt.TV) | total Volume in tissue compartments; millimeter (mm)^3 | baseline and month 12 |
| Tibial Trabecular Volume (Tb.TV) | Volumes in trabecular compartments; mm^3 | baseline and month 12 |
| Tibial Cortical Volume (Ct.TV) | Volumes in cortical compartments; mm^3 | baseline and month 12 |
| Tibial Cortical Perimeter (Ct.Pm) | millimeter; Average periosteal perimeter (all slices) | baseline and month 12 |
| Tibial Trabecular Bone Volume Fraction (Tb.BV/TV) | Volume ratio of bone in trabecular compartment percentage | baseline and month 12 |
| Tibial Trabecular Thickness (Tb.Th) | Average thickness of trabeculae in mm | baseline and month 12 |
| Tibial Trabecular Separation (Tb.Sp) | Avg distance between trabeculae in mm | baseline and month 12 |
| Tibial Inhomogeneity of Trabecular Network | Volume ratio of pores in cortical compartment | baseline and month 12 |
| Tibial Cortical Porosity (Ct.Po) | Volume ratio of pores in cortical compartment | baseline and month 12 |
| Tibial Cortical Pore Diameter (Ct.Po.Dm) | Average 3D diameter of pore volumes | baseline and month 12 |
| Tibial Cortical Pore Volume (Ct.Po.V) | Total volume of cortical pores | baseline and month 12 |
| Tibial Estimated Failure Load (FL) | 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 | Reaction force divided by displacement | baseline and month 12 |
| Bone Formation Assay | Procollagen type I N-propeptide (PINP) is a biomarker of bone formation (mcg/L) | baseline, month 6, month 12 |
| Bone Resorption Assay | C-terminal telopeptide of type I collagen (CTX) is a biomarker of bone resorption (pg/mL) | baseline, month 6, month 12 |
| Atrium Health Wake Forest Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |