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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01482858
Eligibility Criteria:
Inclusion Criteria:
* Osteoporotic patients aged 18-80 years old, inclusive.
* Diagnosed Osteoporotic vertebral compression fracture(s) in at least one vertebra caused by an atraumatic event or a minimal traumatic event such as falling from standing height or less, or by other minimal trauma besides a fall (see section 4.2 Table I for definitions), and visible by either X-ray radiography, CT or MRI.
* At least six (6) weeks and no more than six (6) months from the onset of severe back pain suspected to be caused by the OVCF.
* Presenting a score of ≥5 in the pain NRS during movement (getting up from a chair).
* Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
* Subject that had signed the ICF.
Exclusion Criteria:
* More than six (6) months from the onset of severe back pain suspected to be caused by OVCF.Subjects after vertebroplasty or kyphoplasty.
* Hypercalcemic subjects (calcium \> 10.50 mg/dL).
* Subjects with renal diseases.
* Subjects with active malignancy or other active metabolic bone disease which is not osteoporosis.
* Subjects with cognitive impairments.
* Pregnant or breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01482858
Study Brief:
Protocol Section:
NCT01482858