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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT01218035
Eligibility Criteria:
Inclusion Criteria:
* Degenerative hip osteoarthritis as the indication for hip replacement
* Postmenopausal female patient
* Age of at least 20 years
* Signed Informed Consent
Exclusion Criteria:
* Evidence of secondary osteoporosis
* Clinical or laboratory evidence of hepatic or renal disease
* Disorders of parathyroid function, or D-vitamin metabolism
* History of malignancy, radiotherapy, or chemotherapy for malignancy (except for basal cell carcinoma of the skin) within the past 5 years
* No metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
* Administration for more than 7 days of drugs, which may interfere with bone metabolism:
* cumulative dose of 500 mg of prednisone or equivalent within the last 6 months
* calcitonin within the last 6 months
* bisphosphonates for 30 days or more within the last 12 months
* bone therapeutic doses of fluoride for 30 days or more within the last 24 months
* Rheumatoid arthritis or any other inflammatory arthritis
* History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
* Active primary hyperparathyroidism
* History of uveitis, iritis, or chronic conjunctivitis
* History of retinopathy or nephropathy, especially in the presence of uncontrollable IDDM (Hb1AC \> 10%)
* AST or ALT \> 2X the upper limit of normal
* ALP \> 1.5X the upper limit of normal
* Serum creatine \> 2 mg/dl
* Creatine clearance \< 40 ml/min
* Serum calcium \> 11.0 mg/dL and \< 8mg/dL
* Serum 25(OH)D \< 15 ng/ml
* In subjects with HIV must have a plasma HIV-1 RNA level of \< 5000, a CD4+ count of \> 100 cells/mm3m and be receiving stable ART for a minimum of 12 weeks prior study entry, with no plan at study entry to significantly alter ART
* Allergy to zoledronic acid
* Severe dental problems or current dental infections or with recent or impending dental surgery within three months of dosing
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT01218035
Study Brief:
Protocol Section:
NCT01218035