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

Osteoporosis, Age-Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467400
• Other study ID #: 14-004305
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2015
• Est. completion date: April 1, 2018

Study information

• Verified date: February 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 1, 2018
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Age-Related

Intervention

Drug:
• Atenolol
beta blocker
• Nebivolol
beta blocker
• Propranolol
beta blocker
• placebo
placebo

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of serum bone formation to bone resorption marker	Serum bone formation marker (PINP)/serum bone resorption marker (CTX)	20 weeks