Actively Recruiting

Phase 4
Age: 60Years +
All Genders
NCT05764733

Bone, Exercise, Alendronate, and Caloric Restriction

Led by Wake Forest University Health Sciences · Updated on 2025-12-17

900

Participants Needed

2

Research Sites

220 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Bone, Exercise, Alendronate, and Caloric Restriction

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Community-dwelling older adults
  • Body mass index (BMI) over 30 kg/m2 or BMI between 25.0 and less than 30 kg/m2 with one risk factor
  • Currently receiving routine annual dental care
  • Pre-existing low bone mass with T-score between -1.1 and -2.5 at the hip, femoral neck, or lumbar spine (L1-L4)
Not Eligible

You will not qualify if you...

  • Weight greater than 450 lbs
  • Living with someone currently participating in this study
  • Dependent on a quad cane or walker or unable to walk independently
  • History or evidence of cognitive impairment (score less than 20 on Montreal Cognitive Assessment)
  • Excessive alcohol use (more than 21 drinks per week) in the past month or any non-cannabis illicit drug use
  • Weight change of 5% or more in the past 3 months
  • Regular participation in structured strength training over 60 minutes per day on more than 3 days per week for over 6 months
  • Severe arthritis, fracture, chronic injury, or musculoskeletal disorder preventing safe exercise; recent or planned joint replacement or orthopedic surgery within 6 months or 12 months respectively; recent or planned invasive dental procedures within 6 months
  • Osteoporosis diagnosis or treatment history including prior fractures not caused by trauma or fall from height, or high fracture risk at screening
  • Uncontrolled hypertension (systolic over 180 or diastolic over 110 mmHg) after repeated checks
  • Uncontrolled type 2 diabetes (HbA1c over 8%), dialysis, abnormal kidney or liver function, anemia, abnormal calcium levels, uncontrolled thyroid disease or recent hormone adjustments, vitamin D deficiency
  • Recent serious cardiovascular events or hospitalization within 6 months, chronic respiratory disease requiring oxygen, peripheral artery disease diagnosis within 12 months, uncontrolled angina, progressive neurological disease, malabsorption disorder, life expectancy less than 3 years, bilateral hip replacement, past or planned bariatric surgery, recent cancer treatment, major vision or hearing loss, unstable gastric reflux or certain esophageal disorders
  • Daily use of growth hormones, weight loss medications, oral steroids, diabetes medications such as insulin or others listed; allergy to bisphosphonates; prior use of bisphosphonates or certain bone medications within specified time frames; history of long-term antiresorptive therapy
  • Unable or unwilling to provide transportation, follow study protocol including randomization, or attend data collection visits
  • Current participation in other intervention research studies; planned out-of-town trip over 1 month during first 6 months; unwillingness to provide informed consent or access to health records; judged unsuitable by research team for any reason

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

Loading map...

Research Team

C

Christa Todoroff Calderone, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here