The Bone, Exercise, Alendronate, and Caloric Restriction Trial
Wake Forest University Health Sciences
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.
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 tot…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBisphosphonate
Medicine used to treat bone problems, called osteopenia or osteoporosis.
- BehavioralResistance Training/Bone-Loading Exercise
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.
- OtherPlacebo
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.
Locations (2)
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Atrium Health Wake Forest Baptist Medical CenterWinston-Salem, North Carolina