Atenolol for the Prevention of Osteoporosis (APO)

Overview

About this study

The purpose of this study is to evaluate whether atenolol is effective and safe for the prevention of bone loss in postmenopausal women.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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 (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 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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Closed for enrollment

Contact information:

Tammie Volkman R.N.

(507)538-6023

Volkman.Tammie@mayo.edu

More information

Publications

Publications are currently not available