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Atenolol for the Prevention of Osteoporosis (APO) (APO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04905277
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : July 29, 2021
Sponsor:
Collaborators:
Columbia University
MaineHealth
University of California, San Francisco
Information provided by (Responsible Party):
Sundeep Khosla, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Atenolol 50 MG Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Atenolol vs. Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 3, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : June 21, 2024
Estimated Study Completion Date : January 20, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol

Arm Intervention/treatment
Experimental: Atenolol
Study subjects will take Atenolol 50 mg daily over 2 years
Drug: Atenolol 50 MG
50 mg Atenolol daily
Other Name: Atenolol

Placebo Comparator: Placebo
Study subjects will take a placebo daily over 2 years
Drug: Placebo
one placebo daily




Primary Outcome Measures :
  1. Primary Outcome: Percent change in femur neck bone mineral density (BMD) [ Time Frame: Baseline, 24 months ]
    Percent change in femur neck bone mineral density (BMD) by DXA


Secondary Outcome Measures :
  1. Secondary Outcomes: Percent changes in lumbar spine and total hip BMD [ Time Frame: Baseline, 24 months ]
    Percent changes in lumbar spine and total hip BMD



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905277


Contacts
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Contact: Tammie Volkman, RN 507-538-6023 volkman.tammie@mayo.edu
Contact: Amanda Tweed 507-255-6663 TWEED.AMANDA@MAYO.EDU

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Sundeep Khosla, M.D.
Columbia University
MaineHealth
University of California, San Francisco
Investigators
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Principal Investigator: Sundeep Khosla, MD Mayo Clinic
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Responsible Party: Sundeep Khosla, M.D., Dr. Francis Chucker and Nathan Landow Research Professor Distinguished Mayo Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04905277    
Other Study ID Numbers: 18-005725
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atenolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action