← Back to Search

Bisphosphonate

Alendronate + Exercise for Osteoporosis (BEACON Trial)

Phase 3
Recruiting
Led By Kristen Beavers, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12
Awards & highlights

Summary

This trial aims to find ways to reduce bone loss during weight loss in older adults. It requires up to 9 visits over 2 years.

Who is the study for?
Adults with a BMI over 30, or over 25 with a risk factor, who have low bone mass but not full-blown osteoporosis can join. They must be able to walk without assistance, get regular dental care, and commit to the study visits for up to two years.
What is being tested?
The trial is testing if bisphosphonates (a type of medication) and resistance training exercises can help minimize bone loss during weight loss in older adults. Participants will also explore the effects of caloric restriction on bone health.
What are the potential side effects?
Bisphosphonates may cause digestive issues like heartburn, muscle or joint pain, and rarely jawbone problems. Resistance training might lead to muscle soreness or injury if not done correctly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in total hip areal bone mineral density (aBMD)
Secondary study objectives
Tibial Cortical (Ct.) BMD
Tibial Cortical Thickness (Ct.Th)
Tibial Trabecular (Tb) BMD
+3 more
Other study objectives
Bone Formation Assay
Bone Resorption Assay
Tibial Bone Stiffness
+16 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Resistance Training (RT) + Bisphosphonate (BIS)Experimental Treatment2 Interventions
Progressive Resistance Training (RT) and Bone-Loading Exercise + 70 mg/weekly dose alendronate
Group II: No RT + BISExperimental Treatment1 Intervention
No Resistance Training + 70 mg/weekly dose alendronate
Group III: No RT + Placebo (PL)Active Control1 Intervention
No Resistance Training + Weekly Placebo
Group IV: RT + PLActive Control2 Interventions
Progressive RT and Bone-Loading Exercise + Weekly Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bisphosphonate
2016
Completed Phase 3
~10560

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,007 Total Patients Enrolled
2 Trials studying Osteoporosis
194 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,303 Total Patients Enrolled
23 Trials studying Osteoporosis
12,195 Patients Enrolled for Osteoporosis
Kristen Beavers, PhDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Bisphosphonate (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT05764733 — Phase 3
Osteoporosis Research Study Groups: Resistance Training (RT) + Bisphosphonate (BIS), No RT + BIS, No RT + Placebo (PL), RT + PL
Osteoporosis Clinical Trial 2023: Bisphosphonate Highlights & Side Effects. Trial Name: NCT05764733 — Phase 3
Bisphosphonate (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764733 — Phase 3
~467 spots leftby Apr 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top