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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
900
Medicine used to treat bone problems, called osteopenia or osteoporosis.
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.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGAtrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
RECRUITINGChange in total hip areal bone mineral density (aBMD)
Dual X-ray absorptiometry (DXA) derived
Time frame: from baseline through month 12
aBMD assessment of the femoral neck
DXA derived
Time frame: baseline, month 6, month 12
aBMD assessment of the lumbar spine
DXA derived
Time frame: baseline, month 6, month 12
Tibial Trabecular (Tb) BMD
HR-pQCT acquired; Average volumetric BMD \[mg/cm3\]
Time frame: baseline and month 12
Tibial Cortical (Ct.) BMD
HR-pQCT acquired; Avg. volumetric BMD \[mg/cm3\]
Time frame: baseline, month 6, month 12
Tibial Trabecular Number (Tb.N)
Average number trabeculae per unit length
Time frame: baseline and month 12
Tibial Cortical Thickness (Ct.Th)
Average thickness of cortical compartment in mm
Time frame: baseline and month 12
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