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:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT01078805
Eligibility Criteria:
Inclusion Criteria:
* Men and women who are judged by the study physician to be suitable for FORTEO therapy. The FORTEO product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture
Exclusion Criteria:
* Subjects who have an increased baseline risk for osteosarcoma. These include Paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton
* Subjects who have administered FORTEO or PTH therapy for more than two weeks directly before study entry
* Subjects who have completed a course of FORTEO or PTH therapy of at least 18 months duration before study entry
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01078805
Study Brief:
Protocol Section:
NCT01078805