Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis
 therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will
 increase bone mineral density more than either one alone in postmenopausal osteoporotic
 women.
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.