Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
With
Amgen
Age
45–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Must satisfy A and B and C and D below:
(A) Women aged \> 55
(B) Postmenopausal
(C) Osteoporotic with high risk of fracture
You may not be if
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.
