Atenolol for the Prevention of Osteoporosis (APO)

NCT04905277 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 18-005725
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Percent change in total hip bone mineral density (BMD)

  Percent change in total hip bone mineral density (BMD) by DXA

  Baseline, 24 months

Secondary Outcomes (2)

• Secondary Outcomes: Percent changes in lumbar spine and femur neck BMD

  Baseline, 24 months

• Additional secondary outcomes

  Baseline, intermediate timepoints, 24 months

Study Arms (2)

Atenolol

EXPERIMENTAL

Study subjects will take Atenolol 50 mg daily over 2 years

Drug: Atenolol 50 MG

Placebo

PLACEBO COMPARATOR

Study subjects will take a placebo daily over 2 years

Drug: Placebo

Interventions

Atenolol 50 MG DRUG

50 mg Atenolol daily

Also known as: Atenolol

Atenolol

Placebo DRUG

one placebo daily

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide informed consent
• Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
• Aged 50-75 years

You may not qualify if:

• Clinical diagnosis of diabetes mellitus requiring insulin
• Clinically significant abnormality in any of the additional screening laboratory studies
• A1c- ≥8
• Calcium - \> upper limit lab value per site
• AST- 2x upper normal limit
• FSH- \< 16IU/L
• eGFR- \< 45 mL/min/1.73m2 based on creatinine
• CBC- Per PI interpretation of each patient
• 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)

Sponsors & Collaborators

• Sundeep Khosla, M.D.: lead
• Columbia University: collaborator
• MaineHealth: collaborator
• University of California, San Francisco: collaborator

Study Sites (3)

MaineHealth

Scarborough, Maine, 04074, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Atenolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Sundeep Khosla, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Francis Chucker and Nathan Landow Research Professor Distinguished Mayo Investigator

Model Details: Atenolol vs. Placebo

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: July 27, 2021
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)