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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00120757
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant
* Non menopausal women
* Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%)
* HIV infection known for at least 5 years
* CD4 cell count over 50/mm3
* Karnofsky score over or equal to 70
* Written informed consent.
Exclusion Criteria:
* Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria
* Testosterone below normal if treatment is hormonal
* BMI below or equal to 18
* Severe lung failure
* Chronic alcohol intoxication
* Ongoing opportunistic infection
* Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months
* History of treatment for osteoporosis
* History of malignancy in the previous 5 years (except skin cancer and Kaposi)
* Cytotoxic chemotherapy or cytokine therapy
* Liver cirrhosis
* Breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00120757
Study Brief:
Protocol Section:
NCT00120757