Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01430104
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT01430104
Study Brief:
Protocol Section:
NCT01430104