Atenolol for Osteoporosis Prevention

(APO Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if atenolol, a common beta blocker, can prevent bone loss in postmenopausal women, specifically targeting the lower back and hip. Participants will take either atenolol or a placebo daily for two years to compare results. Ideal candidates are postmenopausal women who have not had a period for at least a year and meet certain health criteria. As a Phase 2 trial, this research measures atenolol's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study demonstrated that atenolol is safe for humans. Atenolol, a beta-blocker commonly used to treat high blood pressure and heart conditions, is generally well-tolerated by the body.

This trial tests atenolol for preventing osteoporosis, and its long history of use provides reassurance about its safety. Side effects can occur but are usually mild, such as fatigue or cold fingers and toes. Serious side effects are rare.

Since this trial is in a middle phase, atenolol has already shown a basic level of safety. While some risk remains, past research suggests the treatment is relatively safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoporosis?

Unlike standard osteoporosis treatments, which typically include bisphosphonates, hormone therapy, or calcium and vitamin D supplements, atenolol is a beta-blocker traditionally used for high blood pressure. Researchers are intrigued by atenolol's potential to prevent bone loss by reducing sympathetic nervous system activity, which is a novel approach for osteoporosis. This unique mechanism could offer a new way to protect bone health, especially for those who cannot tolerate existing osteoporosis medications.

What evidence suggests that atenolol might be an effective treatment for osteoporosis prevention?

Research has shown that atenolol, a common medication for lowering blood pressure, might help prevent bone loss in postmenopausal women. Early studies suggest that atenolol can slightly improve bone structure, such as increasing bone volume in certain areas. Additionally, there are indications that atenolol might thicken the outer layer of the bone, potentially strengthening bones. Although atenolol is primarily used for heart-related issues, its potential benefits for bone health represent an exciting research area. In this trial, participants will receive either atenolol or a placebo to further investigate these potential benefits. As more studies are conducted, clearer evidence may emerge. ^{1 2 4 5 6}

Who Is on the Research Team?

Sundeep Khosla, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

I am a postmenopausal woman.

Able and willing to provide informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04905277

Study Details | NCT04905277 | Atenolol for the Prevention ... Study Overview​​ Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.

2. mayo.edu mayo.edu/research/clinical-trials/cls-20472607

Atenolol for the Prevention of Osteoporosis (APO) The purpose of this study is to evaluate whether atenolol is effective and safe for the prevention of bone loss in postmenopausal women.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161496/

Atenolol, alone or in combination with PTH, has a modest ... Atenolol treatment led to minimal effects including increased total volume in the primary spongiosa (Table 1) and increased medullary area in the cortical ...

4. withpower.com withpower.com/trial/phase-3-6-2021-55616

Atenolol for Osteoporosis Prevention · Info for Participants 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 ...

5. mainehealth.org mainehealth.org/news/2021/11/mmcri-begins-study-osteoporosis-prevention-post-menopausal-women

MMCRI begins study on osteoporosis prevention in post- ... The beta blocker Atenolol, commonly used to lower blood pressure, can also help prevent osteoporosis in post-menopausal women.

6. reporter.nih.gov reporter.nih.gov/search/0nw-tI68RkONFCDIJUk2AQ/project-details/10133380

Project Details - NIH RePORTER The proposed studies will rigorously test whether atenolol is efficacious and safe for the prevention of osteoporosis in postmenopausal women and also further ...