Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Inclusion Criteria:

Must satisfy A and B and C and D below:

- (A) Women aged > 55

- (B) Postmenopausal

- (C) Osteoporotic with high risk of fracture

Exclusion Criteria:

- Confirmed serum alkaline phosphatase above upper normal limit with no explanation

- Liver disease (AST or ALT > 2 x upper normal limit).

- Renal disease (serum creatinine > 2.0 mg/dl).

- Hypercalcemia (Ca >10.5 mg/dL)

- Elevated blood PTH (intact PTH > 65 pg/ml)

- Serum 25-OH vitamin D < 20 ng/ml

- HCT < 32%.

- History of malignancy (except basal cell carcinoma) or radiation therapy.

- Significant cardiopulmonary disease including unstable coronary artery disease, stage
D ACC/AHA heart failure or any other condition that the investigator deems may
preclude the subject from participating safely or completing the protocol procedures.

- 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.

- Known congenital or acquired bone disease other than osteoporosis (including
osteomalacia, hyperparathyroidism, Paget's disease)

- Current use or use in the past 6 months of oral bisphosphonate

- Current use or use within the past 3 months of estrogens, selective estrogen receptor
modulators, or calcitonin.

- Use of oral or parenteral glucocorticoids for more than 14 days within the past 6
months.

- Any current or previous use of strontium or any parenteral bisphosphonate.

- Known sensitivity to mammalian cell-derived drug products.

- Known sensitivity to teriparatide or any of its excipients.