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Beta Blocker

Atenolol for Osteoporosis Prevention (APO Trial)

Phase 2
Waitlist Available
Led By Sundeep Khosla, MD
Research Sponsored by Sundeep Khosla, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 50-75 years
Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
Must not have
Undergoing treatment with any medications that affect bone turnover, including the following: adrenocorticosteroids (oral for > 3 months within the past year or year-round use of inhaled corticosteroid use), anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the previous year) pharmacological doses of: thyroid hormone (causing decline of thyroid stimulating hormone below normal, i.e. < 0.3 miU/L) bisphosphonates (within the past 3 yrs; if taken orally >1 month in past 3 years) denosumab, romosozumab, estrogen therapy (does not include creams or suppositories) or treatment with a selective estrogen receptor modulator, or teriparatide/abaloparatide (> 1 month within the past year); aromatase inhibitors (>1 month within the past year), Current use of digitalis glycosides, Thiazides (< 6 months of use prior to screening), Current or within the past 3 months use of beta blockers, Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable), Bilateral hip replacements or metal in both hips, Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency, Resting systolic blood pressure < 115 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)
Presence of documented clinical diagnosis of any of the following: Significant liver or renal disease, Malignancy (current diagnosis including myeloma or melanoma), Radiation (the site PI will determine eligibility on a case-by-case basis), Malabsorption (current clinical diagnosis or actively receiving treatment), Hypoparathyroidism (current clinical diagnosis or actively receiving treatment), Hyperparathyroidism (current clinical diagnosis or actively receiving treatment), Acromegaly, Cushing syndrome, Hypopituitarism, Severe chronic obstructive pulmonary disease, Pheochromocytoma (current clinical diagnosis or actively receiving treatment), History of cardiac failure, Ejection Fraction <35% (based on most recent EF within the last 12 months, if available), PR interval > 200 msec on screening ECG or known heart block, History of bronchospastic disease with treatment (asthma, bronchitis), Gastric Bypass, Parkinson's, Rheumatoid Arthritis, Psoriatic Arthritis, Connective Tissue disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial will evaluate whether atenolol prevents bone loss in postmenopausal women.

Who is the study for?
This trial is for postmenopausal women aged 50-75 who are healthy and can consent to participate. They must not have severe chronic diseases, recent use of certain heart or bone medications, a history of osteoporotic fractures, or very low blood pressure/heart rate.
What is being tested?
The APO trial is testing if atenolol, a common beta blocker medication, can prevent bone loss in the lower back and hip among postmenopausal women. Participants will either receive atenolol or a placebo (a pill with no active drug).
What are the potential side effects?
Atenolol may cause side effects such as tiredness, cold hands and feet, sleep disturbances, slow heartbeat. Since it's given to healthy subjects here for prevention of osteoporosis rather than heart issues, other specific risks should be discussed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 75 years old.
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I am a postmenopausal woman.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a significant health condition like severe liver, kidney disease, or cancer.
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My kidney function is reduced, with an eGFR below 45.
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I have diabetes and need insulin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
: Percent change in femur neck bone mineral density (BMD)
Secondary study objectives
: Percent changes in lumbar spine and total hip BMD
Additional

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtenololExperimental Treatment1 Intervention
Study subjects will take Atenolol 50 mg daily over 2 years
Group II: PlaceboPlacebo Group1 Intervention
Study subjects will take a placebo daily over 2 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atenolol
FDA approved

Find a Location

Who is running the clinical trial?

Sundeep Khosla, M.D.Lead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,766,705 Total Patients Enrolled
MaineHealthOTHER
74 Previous Clinical Trials
43,355 Total Patients Enrolled
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,530 Total Patients Enrolled
Sundeep Khosla, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester
Harvard Medical Sch (Medical School)
Mass Gen Hospital (Residency)
6 Previous Clinical Trials
420 Total Patients Enrolled

Media Library

Atenolol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04905277 — Phase 2
Healthy Subjects Research Study Groups: Atenolol, Placebo
Healthy Subjects Clinical Trial 2023: Atenolol Highlights & Side Effects. Trial Name: NCT04905277 — Phase 2
Atenolol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905277 — Phase 2
~112 spots leftby Mar 2026
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