Bone, Exercise, Alendronate, and Caloric Restriction Study
This study is looking for strategies to reduce bone loss when older adults lose weight. It is testing the effects of a medicine called alendronate (a bisphosphonate, used to treat bone problems like osteopenia or osteoporosis) and resistance training/bone-loading exercises. You might be able to join if you are 60 or older, live in the community, have a BMI over 30 or a BMI between 25 and 30 with an additional risk factor, receive regular dental care, and have low bone mass. The main goal is to see how these interventions affect your total hip bone mineral density (a measure of bone strength) over 12 months. The study status is currently unclear.
- Study design
- This interventional study plans to enroll 900 participants who will be randomized into one of four groups. It is not specified if the study is blinded.
- What's involved
- Participation involves up to nine assessment visits and lasts up to two years. You will receive a dietary weight loss intervention and, depending on your group, either alendronate, a placebo, or resistance training/bone-loading exercises three days a week.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, change in total hip bone mineral density, is measured from baseline through month 12.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05764733
Bone, Exercise, Alendronate, and Caloric Restriction
Recruiting
PHASE4Ages 60+InterventionalPreventionWake Forest University Health SciencesInvestigator-initiated
~900 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:BisphosphonateResistance Training/Bone-Loading ExercisePlacebo
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in total hip areal bone mineral density (aBMD)
Measured over from baseline through month 12
Conditions
Where it's being run
2 sites across 2 statesColorado1
North Carolina1
Study leadership
- Kristen Beavers, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Change in total hip areal bone mineral density (aBMD)from baseline through month 12
Dual X-ray absorptiometry (DXA) derived