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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00004993
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women on glucocorticoids (prednisone 5mg/d or greater
* Osteopenia by T score of hip or lumbar spine of -2.0
* All study subjects must be on a stable dose of estrogen/progesterone or raloxifene
* Ambulatory and able to come to the clinical center 9 times over 2 years
* Willing to sign an informed consent
Exclusion Criteria:
* Generalized disease of the bone (other than glucocorticoid-induced osteoporosis), including hyperparathyroidism, hyperthyroidism, Paget's disease)
* Diseases that affect bone metabolism (e.g. alcoholism, inflammatory bowel disease, malabsorption, renal disease (Cr2) or liver disease (transaminase level 2 times limit of normal)
* Within the past 1 year, regular use of medications that are known to affect bone metabolism (e.g. anabolic steroids, anticoagulants, anticonvulsants, pharmacologic doses of vitamin D and vitamin A supplements).
* History of drug abuse
* Senile dementia, paraplegia and/or quadriplegia
* Unstable rheumatic disease with clinically significant renal or central nervous system involvement.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00004993
Study Brief:
Protocol Section:
NCT00004993