Anabolic Therapy in Postmenopausal Osteoporosis

Inclusion criteria

• Postmenopausal women at high risk of fracture

Exclusion criteria

• Prior therapy exclusions

• current use or use in the past 12 months of oral bisphosphonates or denosumab
• current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
• use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
• any current or previous use of romosozumab or strontium
• current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.

Other exclusions

• Confirmed serum alkaline greater than 2 times the upper normal limit.
• Stage 4 or 5 chronic kidney disease (GFR less than 30)
• Hypercalcemia (Ca greater than 10.5 mg/dL)
• Hypocalcemia (Ca less than 8.8 mg/dL)
• Elevated blood PTH (intact PTH greater than 77 pg/mL)
• Serum 25-OH vitamin D less than 20 ng/mL
• HCT less than 32%.
• History of malignancy (except basal cell carcinoma).
• Significant pulmonary disease
• History of myocardial infarction or stroke within the preceding year.
• History of unstable angina or transient ischemic attack in the past year.
• Current atrial fibrillation.
• Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
• Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
• Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
• Uncontrolled eczema
• Congenital or acquired bone disease other than osteoporosis.
• Known sensitivity to denosumab or any of its excipients.
• Known sensitivity to romosozumab or any of its excipients.
• History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.