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 - 2 x upper normal limit;
  • FSH- < 16IU/L;
  • eGFR - < 45 mL/min/1.73m^2 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 (liver disease based on abnormal labs; renal disease stage 4 or on dialysis);
  • Malignancy (current diagnosis of any cancer including melanoma and myeloma; for subjects with a previous diagnosis of cancer and no evidence of active or recurrent disease, the site PI will determine eligibility on a case by case basis);
  • Malabsorption (current clinical diagnosis or currently receiving treatment);
  • Chemotherapy or radiation within the past 3 years. (> 3 year history, the site PI will determine eligibility on a case by case basis);
  • Malabsorption (current clinical diagnosis or currently receiving treatment);
  • Hypoparathyroidism (current clinical diagnosis or currently receiving treatment);
  • Hyperparathyroidism (current clinical diagnosis or currently receiving treatment);
  • Acromegaly;
  • Cushing syndrome;
  • Hypopituitarism;
  • Severe chronic obstructive pulmonary disease;
  • Pheochromocytoma (current clinical diagnosis or currently receiving treatment);
  • History of cardiac failure
  • Ejection Fraction <35% (based on most recent EF within the last 12 months, if available);
  • PR interval > 200 msec on screening ECG or known heart block;
  • Active bronchospastic disease with treatment (asthma, bronchitis);
  • Gastric Bypass;
  • Parkinson’s;
  • Rheumatoid Arthritis;
  • Psoriatic Arthritis;
  • Connective Tissue disease;
  • Active Atrial Fibrillation (controlled or uncontrolled).
• Undergoing treatment with any medications that affect bone turnover, including the following:
  • adrenocorticosteroids (oral for > 3 months within the past 12 months or year-round use of inhaled corticosteroids);
  • anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the past 12 months);
  • pharmacological doses of:
    • thyroid hormone (causing decline of thyroid stimulating hormone below normal; i.e. < 0.3 miU/L);
    • bisphosphonates (within the past 3 years [if taken orally > 1 month in past 3 years);
    • denosumab, romosozumab (within the past 12 months);
  • • estrogen therapy (> 1 month in the 12 months *does not include creams and suppositories;
    • selective estrogen receptor modulator; or
    • teriparatide/abaloparatide (> 1 month within the past 12 months).
  • Current use of calcium channel blockers.
  • 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.
  •  
  • Thiazides (< 6 months of use prior to screening).
• Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable).
• Bilateral hip replacement or metal in both hips.
• Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency.
• Resting systolic blood pressure < 115 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff).

Eligibility last updated 4/28//22. Questions regarding updates should be directed to the study team contact.