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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
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 6, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12
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 moreOther study objectives
Bone Formation Assay
Bone Resorption Assay
Tibial Bone Stiffness
+16 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
1,395 Previous Clinical Trials
2,459,505 Total Patients Enrolled
2 Trials studying Osteoporosis
194 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,187,632 Total Patients Enrolled
24 Trials studying Osteoporosis
12,255 Patients Enrolled for Osteoporosis
Kristen Beavers, PhDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a quad cane or walker to move around.My blood pressure is not higher than 180/110 mmHg.My weight is under 450 lbs.I have osteoporosis, confirmed by medication, fractures after 40, or high FRAX scores.I get dental check-ups at least once a year.I cannot safely exercise due to severe arthritis, injury, or recent/planned surgery.My bone density test shows I have low bone mass.I have not had major heart, lung, or neurological issues, or surgeries affecting my weight or eating in the last year.I don't use daily growth hormones, steroids, or specific diabetes meds. No allergies to bisphosphonates, and I haven't used certain bone treatments recently.My BMI is over 25 and I have at least one risk factor.
Research Study Groups:
This trial has the following groups:- Group 1: Resistance Training (RT) + Bisphosphonate (BIS)
- Group 2: No RT + BIS
- Group 3: No RT + Placebo (PL)
- Group 4: RT + PL
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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