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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Adrenergic beta-Antagonists; Atenolol; Nebivolol; Propranolol

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