Healthy
Conditions
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.
Interventions
DRUGAtenolol 50 MG
50 mg Atenolol daily
DRUGPlacebo
one placebo daily
Sponsors
Sundeep Khosla, M.D.
Columbia University
MaineHealth
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Atenolol vs. Placebo
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome: Percent change in total hip bone mineral density (BMD) | Baseline, 24 months | Percent change in total hip bone mineral density (BMD) by DXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcomes: Percent changes in lumbar spine and femur neck BMD | Baseline, 24 months | Percent changes in lumbar spine and femur neck BMD |
| Additional secondary outcomes | Baseline, intermediate timepoints, 24 months | Percent changes in radius and ultra-distal radius BMD using DXA and in bone turnover markers (CTx, PINP). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSundeep Khosla, MD
Mayo Clinic
Outcome results
None listed