Study Summary
This trial will compare the effects of weight loss with and without additional interventions on indicators of bone health.
Eligible Conditions
- Osteoporosis
- Weight Loss
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 10 Secondary · Reporting Duration: 12 months from baseline
12 months from baseline
CTX (pg/mL)
Change in distal radius areal bone mineral density (aBMD)
Change in femoral neck areal bone mineral density (aBMD)
Change in femoral neck volumetric bone mineral density (vBMD)
Change in lumbar spine areal bone mineral density (aBMD)
Change in lumbar spine volumetric bone mineral density (vBMD)
Change in total body fat mass (kg)
Change in total body lean mass (kg)
Change in total hip areal bone mineral density (aBMD)
Cognitive Assessment
Cortical thickness (mm)
D3-Creatine derived muscle mass measured in kg
Fatigability
Finite element (FE) modeling of bone strength measured in kN
Gait speed
Grip strength
Intermuscular fat CSA (cm2)
Lower Extremity
Mid-thigh intermuscular fat measured in cm3
Mid-thigh muscle density measured in HU
Mid-thigh muscle volume measured in cm3
P1NP (ug/L)
Pain and Fatigue
Physical activity among older adults
Stair climbing time
Timed-Up-and-Go (TUG)
Trabecular bone score (TBS)
expanded Short Physical Performance Battery (eSPPB)
6 months from baseline
Change in total hip trabecular volumetric bone mineral density (vBMD)
Overall limb loading
Overall satisfaction participating in the optional insole visits
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Weight Loss Plus Resistance Exercise Training
1 of 3
Weight Loss
1 of 3
Weight Loss plus Vest
1 of 3
Active Control
Experimental Treatment
150 Total Participants · 3 Treatment Groups
Primary Treatment: weight loss program · No Placebo Group · N/A
Weight Loss plus VestExperimental Group · 2 Interventions: weight loss program, Vest · Intervention Types: Behavioral, Device
Weight Loss Plus Resistance Exercise TrainingActiveComparator Group · 2 Interventions: Resistance Exercise Training, weight loss program · Intervention Types: Behavioral, Behavioral
Weight Loss
Behavioral
ActiveComparator Group · 1 Intervention: weight loss program · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
weight loss program
2012
Completed Phase 3
~30
Vest
2014
N/A
~40
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months from baseline
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,125 Previous Clinical Trials
1,127,033 Total Patients Enrolled
1 Trials studying Osteoporosis
187 Patients Enrolled for Osteoporosis
Kristen Beavers, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
200 Total Patients Enrolled
Eligibility Criteria
Age 60 - 85 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Waist circumference - Men: >102 cm; Women: >88 cm HDL cholesterol level - Men: <40 mg/dL and Women: <50 mg/dL Triglyceride level - Men: >150 mg/dL and Women: >200 mg/dL
If you have a BMI of 30-40 kg/m^2 or a BMI of 27.0-<30.0 kg/m^2 plus one risk factor, you are at an increased risk for heart disease
I am willing to participate in this study and agree to all study procedures
I am willing to complete online/electronic study forms and participate in virtual group sessions, as needed.
No health concerns exist that should prevent someone from safely participating in an exercise program, or using a weight vest.
Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Miller, Ryan M., Daniel P. Beavers, Peggy M. Cawthon, Charlotte Crotts, Jason Fanning, James Gerosa, Katelyn A. Greene, et al.. 2021. “Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106326.
- 2020. "Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04076618.
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Conditions
Cancer Related
Treatments