Status:
ACTIVE_NOT_RECRUITING
Atenolol for the Prevention of Osteoporosis (APO)
Lead Sponsor:
Sundeep Khosla, M.D.
Collaborating Sponsors:
Columbia University
MaineHealth
Conditions:
Healthy
Eligibility:
FEMALE
50-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04905277
Start Date
July 27 2021
End Date
March 31 2026
Last Update
August 14 2025
Active Locations (3)
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1
MaineHealth
Scarborough, Maine, United States, 04074
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Columbia University Irving Medical Center
New York, New York, United States, 10032