Atenolol for the Prevention of Osteoporosis (APO)

  • STATUS
    Recruiting
  • End date
    Jan 20, 2025
  • participants needed
    420
  • sponsor
    Sundeep Khosla, M.D.
Updated on 6 August 2021

Summary

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

Details
Condition healthy
Treatment Placebo, Atenolol 50 MG
Clinical Study IdentifierNCT04905277
SponsorSundeep Khosla, M.D.
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

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 (including myeloma or clinical diagnosis of MGUS)
Malabsorption (as defined by clinical diagnosis)
Hypoparathyroidism (as defined by clinical diagnosis)
Hyperparathyroidism (as defined by clinical diagnosis)
Acromegaly
Cushing syndrome
Hypopituitarism
Severe chronic obstructive pulmonary disease
Pheochromocytoma
History of cardiac failure
Ejection Fraction <35%
PR interval > 200 msec on screening ECG or known heart block
History of bronchospastic disease
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 sustained 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) denosumab, romosozumab, estrogen therapy or treatment with a selective estrogen receptor modulator, or teriparatide/abaloparatide (within the past year)
Current use of calcium channel blockers
Current use of digitalis glycosides
Current or within the past 3 months use of thiazide diuretics
Current or within the past 3 months use of beta blockers
Clinical history of osteoporotic fracture (vertebral, hip, distal forearm, humerus, or pelvis), or any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable)
Evidence of moderate/severe vertebral deformity based on DXA vertebral fracture assessment at screening
Spine or femur neck T-score -2.5, or 1/3 radius T-score -3, as they may be candidates for standard osteoporosis drugs
Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency
Resting systolic blood pressure < 120 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)
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