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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00371956
Eligibility Criteria:
Inclusion Criteria:
1. Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
2. Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone \<= 10 mg/day or equivalent).
3. Baseline bone mineral density (BMD) of the lumbar spine T score \< -1.0.
Exclusion Criteria:
1. Patients with a history of thromboembolism.
2. Patients with positive antiphospholipid antibodies.
3. History of allergic reactions or intolerance to raloxifene or other SERMs.
4. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
5. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
6. Patients with abnormal uterine bleeding of unknown etiology.
7. Patients with serum creatinine level of \>= 200 umol/L.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00371956
Study Brief:
Protocol Section:
NCT00371956