Osteoporosis, Age-Related
Conditions
Keywords
bone formation
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.
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.
Interventions
DRUGAtenolol
beta blocker
DRUGNebivolol
beta blocker
DRUGPropranolol
beta blocker
DRUGplacebo
placebo
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of serum bone formation to bone resorption marker | 20 weeks | Serum bone formation marker (PINP)/serum bone resorption marker (CTX) |
Countries
United States
Outcome results
None listed