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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT01155232
Eligibility Criteria:
Inclusion Criteria:
* History of fragility fracture OR
* High risk for fractures OR
* Very low BMD (T-score ≤ -2.5) OR
* Failed or intolerant to bisphosphonates
* Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25- hydroxyvitamin D \[25(OH)D\] must be within acceptable normal limits
* Ability to obtain teriparatide (not supplied by study sponsor)
Exclusion Criteria:
* History of skeletal irradiation
* Those at increased risk for osteosarcoma
* Diagnosis of Paget's disease
* History of primary hyperparathyroidism
* Significant renal impairment
* Vitamin D deficiency
* On steroids or have other causes of secondary osteoporosis
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01155232
Study Brief:
Protocol Section:
NCT01155232