Recruiting

Alendronate & Exercise

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05764733

Conditions

Bone Loss

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Bisphosphonate

Resistance Training/Bone-Loading Exercise

Placebo

Study Details

Brief 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

Study ID

NCT05764733

Start date

Jun 8, 2023

Status verified date

Dec, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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))
  • Excessive alcohol use (>21 drinks/week) in the past month; any non-cannabis illicit drug use
  • Weight change ≥5% in past 3 months
  • Regular participation (>60 mins per day on > 3 days/week) in structured strength training program for >6 months
  • Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents safe exercise participation; joint replacement or other orthopedic surgery in past 6 months or planned in next 12 months; invasive dental procedure (i.e. extraction/implant) in past 6 month or planned in next 12 months
  • Osteoporosis (any of the following): Self-reported and on prescription osteoporosis medication; self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height), including atypical femoral fractures (AFF); or ≥20% for major osteoporotic fracture at screening
  • Uncontrolled hypertension (systolic >180 OR diastolic >110 mmHg) upon repeated assessments (up to 3 times)
  • Uncontrolled type 2 diabetes (HbA1c >8%); dialysis or abnormal kidney function (eGFR <45 mL/min/1.73 m2); liver disease or abnormal liver function (ALT levels 2 times above normal); anemia (Hb<LLN); calcium above or below normal limit; uncontrolled thyroid disease (hypo/hyper) or requiring recent (past 3 months) adjustments in thyroid hormone supplementation or thyroid-stimulating hormone <LLN or >10 mIU/ml; vitamin D deficiency (<20 ng/mL).
  • Stroke, heart attack, heart failure hospitalization, or revascularization procedure within the past 6 months; chronic respiratory disease requiring oxygen; PAD diagnosis within the last 12 months; uncontrolled angina; progressive neurological disease; malabsorption disorder; any disease suggesting a life-expectancy <3 years; bilateral hip replacement; past or planned bariatric surgery; cancer requiring initial treatment within the last 12 months (except non-melanoma skin cancers); major vision or hearing loss; unstable gastric reflux; esophageal stricture, achalasia, or Barrett's esophagus
  • Daily use of growth hormones, weight loss medications, oral steroids, or diabetes prescriptions (such as insulin, thiazolidinediones, or canagliflozin); known allergy to bisphosphonates; prior use of oral bisphosphonates for >3 months within the past 3 years; zoledronic acid within the past 5 years; denosumab use within the past year; anabolic agents for >3 months in the last year; current use of biotin or strontium; history of 3+ years of antiresorptive therapy
  • Unable/unwilling to: provide own transportation to study visits, commit to study protocol (including random assignment), or adhere to data collection visits
  • Current participation in another intervention research study; planned out-of-town trip greater than 1 month at a time during the first 6 months of the study; unwilling to provide informed consent, including consent to access personal electronic health records; judged unsuitable for the trial for any reason by research team

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Bisphosphonate

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

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.

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christa Todoroff Calderone, M.S.

336-758-5019todorocm@wfu.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sarah Wherry, PhD

sarah.wherry@cuanschutz.edu

Principal Investigator:

Sarah Wherry, PhD

Atrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Kristen Beavers, PhD

336-758-5855kristen.beavers@wfusm.edu

Christa Todoroff Calderone, M.S.

336-758-5019todorocm@wfu.edu

Principal Investigator:

Kristen Beavers, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 9, 2026

Last verified

Dec, 2025

Keywords

  • Older Adults
  • Weight Loss
  • Resistance Training
  • Osteoporosis
  • Osteopenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-09.