Atenolol for Osteoporosis Prevention

(APO Trial)

Recruiting at 2 trial locations

Overseen By Amanda Tweed

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Sundeep Khosla, M.D.

Must not be taking: Beta blockers, Corticosteroids, Anticonvulsants, Estrogen

Disqualifiers: Diabetes, Liver disease, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

420 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.

Will I have to stop taking my current medications?

The trial requires that participants not be on certain medications that affect bone turnover, such as steroids, anticonvulsants, and some hormone therapies. If you are currently using any of these, you may need to stop them to participate in the trial.

Is atenolol generally safe for humans?

Atenolol is generally well tolerated in humans, with some mild side effects like cold extremities, headache, dizziness, breathlessness, and bradycardia (slow heart rate) reported in a small percentage of patients. It has been used safely for many years in treating heart-related conditions. ^{1 2 3 4 5}

How does the drug Atenolol differ from other treatments for osteoporosis prevention?

Atenolol is primarily a beta-blocker used for heart conditions, and its potential use in osteoporosis prevention is novel because it may affect bone health through mechanisms related to the sympathetic nervous system and endothelial function, which are shared with cardiovascular diseases. Unlike traditional osteoporosis treatments, Atenolol's role in bone health is still under investigation and not yet established. ^{2 3 6 7 8}

Research Team

Sundeep Khosla, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am between 50 and 75 years old.

Able and willing to provide informed consent

I am a postmenopausal woman.

Exclusion Criteria

A1c- ≥8

CBC- Per PI interpretation of each patient

I have a significant health condition like severe liver, kidney disease, or cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Atenolol 50 mg daily or placebo for 2 years

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atenolol
• Placebo

Trial Overview 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).

Participant Groups

Group I: Atenolol Experimental Treatment 1 Intervention

Study subjects will take Atenolol 50 mg daily over 2 years

Group II: Placebo Placebo Group 1 Intervention

Study subjects will take a placebo daily over 2 years

Who Is Running the Clinical Trial?

Sundeep Khosla, M.D.

Lead Sponsor

Trials

2

Recruited

490+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

References

1. Japan pubmed.ncbi.nlm.nih.gov

Osteoprotective effect of propranolol in ovariectomized rats: a comparison with zoledronic acid and alfacalcidol. [2022]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cardiovascular diseases and osteoporosis: what is common?]. [2015]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Atenolol. A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disorders. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Osteogenic actions of metoprolol in an ovariectomized rat model of menopause. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Monitoring the adverse profile of atenolol--a collaborative study. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Should β blockers no longer be considered first-line therapy for the treatment of essential hypertension without comorbidities? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

β-blockade: benefits beyond blood pressure reduction? [2023]

8. England pubmed.ncbi.nlm.nih.gov

The efficacy and tolerability of antihypertensive treatment based on atenolol in the prevention of stroke and the regression of left ventricular hypertrophy. [2013]