Atenolol for the Prevention of Osteoporosis (APO)

• Status: Recruiting
• Trial end date: 2025-01-20
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sundeep Khosla, M.D.
• Collaborators: Columbia University; MaineHealth; University of California, San Francisco
• Treatments: Atenolol

Criteria

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)