Bone, Exercise, Alendronate, and Caloric Restriction

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05764733
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Bone Loss

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bisphosphonate — DRUG
    Medicine used to treat bone problems, called osteopenia or osteoporosis.
  • 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.
  • Placebo — OTHER
    Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.

Study Details

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.

Key Dates

Start date
Jun 8, 2023
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Resistance Training (RT) + Bisphosphonate (BIS)
    Progressive Resistance Training (RT) and Bone-Loading Exercise \+ 70 mg/weekly dose alendronate
  • Experimental: No RT + BIS
    No Resistance Training \+ 70 mg/weekly dose alendronate
  • Active Comparator: No RT + Placebo (PL)
    No Resistance Training + Weekly Placebo
  • Active Comparator: RT + PL
    Progressive RT and Bone-Loading Exercise + Weekly Placebo

Primary Outcome Measure

Change in total hip areal bone mineral density (aBMD) [ Time Frame: from baseline through month 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Sarah Wherry, PhD
[email protected]
Sarah Wherry, PhD (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Kristen Beavers, PhD
[email protected]
336-758-5855
Christa Todoroff Calderone, M.S.
[email protected]
336-758-5019
Kristen Beavers, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical Campus· Aurora, COAtrium Health Wake Forest Baptist Medical Center· Winston-Salem, NC

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