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Bone, Exercise, Alendronate, and Caloric Restriction

NCT05764733 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Bone Loss

Interventions

DRUG

Bisphosphonate

Medicine used to treat bone problems, called osteopenia or osteoporosis.

BEHAVIORAL

Resistance 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.

OTHER

Placebo

Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kristen Beavers, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05764733 on ClinicalTrials.gov