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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00549068
Eligibility Criteria:
Inclusion Criteria:
* Women diagnosed with postmenopausal osteoporosis using community practice standards
* Women previously non-treated for osteoporosis, OR treated for osteoporosis with biphosphonates (alendronate, etidronate), hormone replacement therapy estrogen, estrogen-related drugs, progesterone, subcutaneous estrogen implant), raloxifene, fluoride, or calcitonin within the past 2 years but discontinued prior to enrolment into the study either due to:lack of effect or intolerance
Exclusion Criteria:
* Subjects treated with Actonelr 5 mg daily,
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Known/Suspected hypersensitivity to any component of Actonelr 35 mg Once-a-Week
* Known/Suspected hypocalcaemia
* Known/Suspected severe renal impairment (creatinine clearance \< 30ml/min)
* Known/Suspected hyperparathyroidism
* Known/Suspected hyperthyroidism
* Known/Suspected active urinary tract infection
* Known high urine levels of calcium (3 4mg/ml)
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:
FEMALE
Minimum Age:
18 Years
Study:
NCT00549068
Study Brief:
Protocol Section:
NCT00549068