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OpenTrials
Completed

NCT Number: NCT04905277

Atenolol for the Prevention of Osteoporosis (APO)

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

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

MaineHealth, Scarborough, Maine, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • 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
  • 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)

Treatment and study plan

Atenolol 50 MG

Drug

50 mg Atenolol daily

Other names: Atenolol

Placebo

Drug

one placebo daily

Primary outcomes

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

    Time frame: Baseline, 24 months

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

Secondary outcomes

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

    Time frame: Baseline, 24 months

    Percent changes in lumbar spine and femur neck BMD

  2. Additional secondary outcomes

    Time frame: Baseline, intermediate timepoints, 24 months

    Percent changes in radius and ultra-distal radius BMD using DXA and in bone turnover markers (CTx, PINP).

Sponsors and collaborators

Lead sponsor

Sundeep Khosla, M.D.

Other

Collaborators

  • Columbia University
  • MaineHealth
  • University of California, San Francisco

Registry information

Official study title

Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 2, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial

Acronym: APO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 27, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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