NCT05764733 Bone, Exercise, Alendronate, and Caloric Restriction
| NCT ID | NCT05764733 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Bone Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2023-06-08 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 900 participants in total. It began in 2023-06-08 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Kristen Beavers, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05764733 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05764733 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05764733 currently recruiting?
Yes, NCT05764733 is actively recruiting participants. Contact the research team at todorocm@wfu.edu for enrollment information.
Where is the NCT05764733 trial being conducted?
This trial is being conducted at Aurora, United States, Winston-Salem, United States.
Who is sponsoring the NCT05764733 clinical trial?
NCT05764733 is sponsored by Wake Forest University Health Sciences. The principal investigator is Kristen Beavers, PhD at Wake Forest University Health Sciences. The trial plans to enroll 900 participants.