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Dose Response and Receptor Selectivity of Beta-blocker Effects on Bone Metabolism

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467400
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sundeep Khosla, M.D., Mayo Clinic

Brief Summary:
This study is designed to answer the question as to whether the sympathetic nervous system is an important determinant of bone metabolism in humans.

Condition or disease Intervention/treatment Phase
Osteoporosis, Age-Related Drug: Atenolol Drug: Nebivolol Drug: Propranolol Drug: placebo Early Phase 1

Detailed Description:
In postmenopausal women, who have increased sympathetic outflow, to test the hypothesis that treatment with low doses of a non-selective β-blocker (propranolol) will increase serum markers of bone formation and reduce markers of bone resorption (Aim 1a); and using increasingly β1-AR (adrenergic receptor) selective blockers (atenolol and nebivolol), to better define the β-adrenergic receptor selectivity (β1 versus β2) in the regulation of bone turnover by sympathetic outflow in humans.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dose Response and Receptor Selectivity of Beta-blocker Effects on Bone Metabolism
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
Sugar pill 2/day for 20 weeks; The once daily groups will receive a placebo as the second dose
Drug: placebo
placebo

Active Comparator: Atenolol
Atenolol 50 mg 1/day for 20 weeks
Drug: Atenolol
beta blocker

Active Comparator: Nebivolol
Nebivolol 5 mg/day for 20 weeks
Drug: Nebivolol
beta blocker

Active Comparator: Propranolol 40 mg
Propranolol 20 mg bid for 20 weeks
Drug: Propranolol
beta blocker

Active Comparator: Propranolol 80 mg
Propranolol 40 mg bid for 20 weeks
Drug: Propranolol
beta blocker




Primary Outcome Measures :
  1. Ratio of serum bone formation to bone resorption marker [ Time Frame: 20 weeks ]
    Serum bone formation marker (PINP)/serum bone resorption marker (CTX)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion Criteria:

    • at least 5 yrs since their last menses
    • Follicle Stimulating Hormone (FSH) > 20 IU/L
  • Exclusion Criteria:

    • Abnormality in any of the screening laboratory studies
    • Presence of significant liver or renal disease
    • Malignancy (including myeloma)
    • Malabsorption
    • Diabetes
    • Hypoparathyroidism
    • Hyperparathyroidism
    • Acromegaly
    • Cushing's syndrome
    • Hypopituitarism
    • Severe chronic obstructive pulmonary disease
    • Undergoing treatment with any medications that affect bone turnover, including the following:
  • adrenocorticosteroids (> 3 months at any time or > 10 days within the previous yr)
  • anticonvulsant therapy (within the previous year)
  • pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
  • calcium supplementation of > 1200 mg/d (within the preceding 3 months)
  • bisphosphonates (within the past 3 yrs)
  • denosumab
  • estrogen (E) therapy within the past year
  • treatment with a selective E receptor modulator within the past year
  • teriparatide within the past yr
  • anti-hypertensive therapy

    • Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm
    • Recent (within the past 6 months) fracture
    • Serum 25-hydroxyvitamin D levels of < 20 ng/ml
    • Resting blood pressure >140/90 mm Hg or those with hypotension (systolic blood pressure <110 mm Hg), heart rate < 60 bpm
    • History of asthma

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): NCT02467400


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sundeep Khosla, MD Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sundeep Khosla, M.D., Professor of Medicine and Physiology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02467400    
Other Study ID Numbers: 14-004305
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sundeep Khosla, M.D., Mayo Clinic:
bone formation
Additional relevant MeSH terms:
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Atenolol
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Propranolol
Nebivolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists