A Study of Teriparatide in Japanese Osteoporosis Patients

Exclusion Criteria

• •Prior treatment with parathyroid hormone (PTH) or any PTH analog
• •History of metabolic bone disorders other than primary osteoporosis
• •Fractures caused by diseases other than osteoporosis
• •Abnormal thyroid function
• •Hyperparathyroidism or hypoparathyroidism
• •Severe or chronically disabling conditions other than osteoporosis
• •Currently has or has a history of spruce, inflammatory bowel disease, or malabsorption syndrome
• •Currently has, or a has a history of, nephrolithiasis or urolithiasis in the 2 years prior to screening
• •Clinically significant abnormal laboratory values or electrocardiogram
• •Treatment with oral bisphosphonates at any time in the 3 months prior to enrollment, treatment with any bisphosphonate for more than 60 days in the 6 months prior to enrollment, or with intravenous bisphosphonates at any time in the 24 months prior to enrollment; or in case of oral bisphosphonates administered once a week, the equivalent as the above
• •Treatment with injectable calcitonin in the 3 months prior to enrollment
• •Treatment with raloxifene hydrochloride for more than 3 months in the 6 months prior to enrollment
• •Treatment with systemic corticosteroids, except for orally inhaled or nasally inhaled corticosteroids, in doses \<= 800 micrograms per day (µg/day) beclomethasone dipropionate or equivalent in the 3 months prior to screening, or for more than 30 days in the 12 months prior to enrollment
• •Treatment with anticonvulsants, except for benzodiazepines, in the 6 months prior to enrollment
• •Prior treatment with strontiumranate or denosumab (anti-RANKL antibody)
• •Prior external beam radiation therapy involving the skeleton
• •Current or a history of malignant neoplasm in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that had been definitively treated