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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00191802
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal woman OR a man at least 30 years of age (who no longer have bone growth)
* In the opinion of the investigator:
* The patient must have severe osteoporosis (defined as a low bone mass AND a fracture related to osteoporosis), and be at high risk for fracture despite currently available therapies
* Patients should have failed or been shown to be intolerant to currently commercially available osteoporosis therapies. (Failure of therapy: fracture, or significant loss of bone mass)
* There should be no other medical causes of the osteoporosis (called idiopathic osteoporosis) except for low estrogen (in women) or low testosterone (in men)
* In the opinion of the investigator, the patient can learn to use the pen type injection delivery system and will be able to use it either alone or with appropriate assistance
* Must be able to understand and sign an approved informed consent document
* Must be able to come in for follow-up visits for the duration of the study.
Exclusion Criteria:
* High blood calcium levels, high parathyroid hormone levels in the blood, high levels of a blood test called alkaline phosphatase that haven't been explained yet.
* Known or suspected bone diseases other than osteoporosis
* Any medical condition that might increase a patient's baseline risk for bone tumors (including prior radiation to the skeleton, Paget's disease, previous bone tumors).
* Recent or currently active kidney stone, OR major problems with kidney function
* Serious ongoing medical problems incompatible with the study (as assessed by the investigator)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00191802
Study Brief:
Protocol Section:
NCT00191802