Clinical Trials

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 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)