EUCTR2011-000628-14-FI进行中（未招募）不适用
Denosumab in enhancement of bone bonding of hip prosthesis in postmenopausal women: a randomized, double-blind, placebo-controlled study - Hip-Prolia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Postmenopausal women, age: = 60 years to = 85 years at randomization
- •Degenerative primary hip OA as the indication of hip replacement
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Presence of severe osteoporosis (T-score less than -4.0)
- •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
- •Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics
- •Rheumatoid arthritis or any other inflammatory arthritis
- •History of skeletal disorder, such as Paget’s disease or osteomalasia
- •Alcohol abuse
- •o Mental, neurological or other conditions that may affect the ability to perform functional or clinical assessments required by the protocol
- •o Subjects with known sensitivity or intolerance to any of the products to be administered
- •o Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge
- •o 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
研究者
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