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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01926158
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
* Degenerative primary hip osteoarthritis as the indication of hip replacement
* Signed informed consent
Exclusion Criteria:
* Presence of severe osteoporosis (T-score less than -4.0 and a previous fracture)
* Presence of Dorr C-type geometric change of the proximal femur
* Evidence of secondary osteoporosis
* Clinical or laboratory evidence of hepatic disease
* Laboratory evidence of hypocalcaemia
* Vitamin D deficiency (serum 25-OH(D) \< 12 ng/mL)
* Disorders of parathyroid function
* Uncontrolled hyperthyroidism or hypothyroidism
* History of malignancy, radiotherapy or chemotherapy for malignancy (except basal cell carcinoma of the skin) within the last 5 years
* History of osteonecrosis of the jaw
* History of recent tooth extraction or other dental surgery and/or invasive dental work planned in the next 2 years
* Severe asthma or chronic obstructive pulmonary disease
* History of solid organ or bone marrow transplant
* Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics:
* Cumulative dose of 500 mg prednisone or equivalent within the last 6 months
* Ever use of oral or iv bisphosphonates
* Ever use of strontium ranelate or fluoride
* Use of the following medications:
* chronic systemic ketoconazole
* androgens
* cinacalcet
* aluminum
* lithium
* protease inhibitors
* gonadotropin-releasing hormone agonists
* Rheumatoid arthritis or any other inflammatory arthritis
* History of skeletal disorder, such as Paget's disease or osteomalacia
* Alcohol abuse
* General
* Mental, neurological or other conditions that may affect the ability to perform functional or clinical assessments required by the protocol
* Subjects with known sensitivity or intolerance to any of the products to be administered (calcium and D-vitamin supplements, denosumab)
* Subject will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge
* Any other condition that, in the judgement of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT01926158
Study Brief:
Protocol Section:
NCT01926158