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 - 2 x upper normal limit;
    • FSH- < 16IU/L;
    • eGFR - < 45 mL/min/1.73m^2 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 (liver disease based on abnormal labs; renal disease stage 4 or on dialysis);
    • Malignancy (current diagnosis of any cancer including melanoma and myeloma; for subjects with a previous diagnosis of cancer and no evidence of active or recurrent disease, the site PI will determine eligibility on a case by case basis);
    • Malabsorption (current clinical diagnosis or currently receiving treatment);
    • Chemotherapy or radiation within the past 3 years. (> 3 year history, the site PI will determine eligibility on a case by case basis);
    • Malabsorption (current clinical diagnosis or currently receiving treatment);
    • Hypoparathyroidism (current clinical diagnosis or currently receiving treatment);
    • Hyperparathyroidism (current clinical diagnosis or currently receiving treatment);
    • Acromegaly;
    • Cushing syndrome;
    • Hypopituitarism;
    • Severe chronic obstructive pulmonary disease;
    • Pheochromocytoma (current clinical diagnosis or currently 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;
    • Active bronchospastic disease with treatment (asthma, bronchitis);
    • Gastric Bypass;
    • Parkinson’s;
    • Rheumatoid Arthritis;
    • Psoriatic Arthritis;
    • Connective Tissue disease;
    • Active Atrial Fibrillation (controlled or uncontrolled).
  • Undergoing treatment with any medications that affect bone turnover, including the following:
    • adrenocorticosteroids (oral for > 3 months within the past 12 months or year-round use of inhaled corticosteroids);
    • anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the past 12 months);
    • pharmacological doses of:
      • thyroid hormone (causing decline of thyroid stimulating hormone below normal; i.e. < 0.3 miU/L);
      • bisphosphonates (within the past 3 years [if taken orally > 1 month in past 3 years);
      • denosumab, romosozumab (within the past 12 months);
      • estrogen therapy (> 1 month in the 12 months *does not include creams and suppositories;
      • selective estrogen receptor modulator; or
      • teriparatide/abaloparatide (> 1 month within the past 12 months).
    • 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.
    •  
    • Thiazides (< 6 months of use prior to screening).
  • Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable).
  • Bilateral hip replacement 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).

Eligibility last updated 4/28//22. Questions regarding updates should be directed to the study team contact.

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.

Open for enrollment

Contact information:

Tammie Volkman R.N.

(507)538-6023

Volkman.Tammie@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20472607

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