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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT00616694
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a variety of rheumatologic, pulmonary, and skin conditions.
* Subjects were to be on oral glucocorticoids with a mean daily dose of greater than or equal to 5.0 mg prednisone (or its equivalent) and were expected (although not required) to remain on a daily dose of greater than or equal to 5.0 mg prednisone (or its equivalent) for 12 months after the study started.
* Women must have been at least one year post-menopausal or surgically sterile.
* Subjects must have had evaluable BMD site at the lumbar spine (LS) and proximal femur.
Exclusion Criteria:
* Subject's unwillingness to take Vitamin D, calcium supplements or study medication
* A history of cancer: any history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
* A history of hyperparathyroidism, hyperthyroidism or osteomalacia or other metabolic bone disease within one year prior to enrollment
* History of alcohol or drug dependence within one year of enrollment
* A history of using any of the following medications within 6 months of starting study drug: Estrogen or estrogen-related drugs (tamoxifen, raloxifene, tibolone); low dose vaginal estrogen (estradiol \< 0.2 mg/day, estropipate \< 1.5 mg/day) will be allowed,Anabolic steroids,Parathyroid hormone
* A history of using any of the following medications within 1 month of starting study drugor for more than 1 month within 6 months prior to study entry: Calcitonin,Vitamin D supplements (\>1000 IU per day),Calcitriol (\>1.5mcg/week)
* A history of using any of the following medications within 6 months of starting study drug or for more than 14 days within 1 year prior to study entry: Any bisphosphonate,Fluoride (\> 10 mg per day),Estrogen implant,Deflazacort
* Have received a depot injection of \> 10,000 IU Vitamin D in the past 12 months
* Have a documented history of an abnormal or allergic reaction to bisphosphonates
* History of recurrent nephrolithiasis or a history of one episode of nephrolithiasis within 5years of study entry
* Severe renal impairment (creatinine clearance of \<30 mL/min)
* Subjects on steroid therapy for transplantation
* Subjects on oral glucocorticoids for \>8 weeks but \<6 months at screening
* History of hypersensitivity to the investigational product or to drugs with similar chemical structures
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT00616694
Study Brief:
Protocol Section:
NCT00616694