JPRN-jRCT2031220657招募中3 期
A randomized, double blind, parallel group, active controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU Prolia in postmenopausal women with osteoporosis
Dong Ying0 个研究点目标入组 45 人开始时间: 2023年2月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 60age old 至 <= 90age old（—）
- 性别
- Female
入选标准
- •1. Participant must sign an ICF, which includes compliance with the requirements and restrictions in the protocol.
- •2. Ambulatory postmenopausal woman at >= 60 to <= 90 years of age.
- •3. Diagnosed with osteoporosis, with absolute BMD consistent with a T-score of <= -2.5 and >= -4.0 at the lumbar spine (L1-L4 region) as measured by DXA.
- •4. Has at least two lumbar vertebrae in L1 L4 region and one hip evaluable by DXA for BMD measurement.
- •5. Body weight >= 50 kg and <= 90 kg
排除标准
- •1. A history and/or presence of severe or more than two moderate vertebral fractures; or a history and/or presence of hip fracture or atypical femur fracture; or presence of any active healing fracture
- •2. BMD absolute value is consistent with a T-score < -4.0 at the total hip or femoral neck
- •3. Evidence of any of the following conditions:
- •- A history of bone disease, such as osteomalacia, osteopetrosis, Paget's disease, or osteogenesis imperfecta
- •- A history of metabolic or other endocrinologic diseases, such as Cushing's disease, hyperprolactinemia, acromegaly, or any gastrointestinal disorders associated with malabsorption (e.g. Crohn's disease and chronic pancreatitis)
- •- A history of chronic inflammatory diseases, sclerosis, osteophytosis, severe scoliosis, or other degenerative changes due to other co-morbidities
- •- A history or current hyper- or hypoparathyroidism
- •- Current uncontrolled hyper- or hypothyroidism
- •- Presence of hypocalcemia and/or vitamin D deficiency
- •- Other disease conditions where there is bone/joint involvement
- •- A history of bilateral hip replacement
- •4. Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years before enrollment
- •5. Liver diseases:
- •- Cirrhosis of the liver
- •- Known history and/or active infection of hepatitis B and/or hepatitis C
- •- Inadequate hepatic function (ALT and/or AST >= 2 X ULN)
- •6. Severe renal disease (eGFR < 30 mL/min)
- •7. Oral/Dental conditions:
- •- Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw
- •- Active dental or jaw condition which requires oral surgery
- •- Invasive dental procedure planned during the study or within the past 6 months
- •- Non-healed dental or oral surgery
- •- Active periodontal disease
- •8. Administration of medications that can affect BMD
- •- Denosumab used at any time prior to Screening visit
- •- Administration of bisphosphonate as follows: 1) oral bisphosphonates at any dose used for > 3 years cumulatively at Screening visit; 2) oral bisphosphonates at any dose used within 1 year prior to Screening visit (if <= 3 years of use cumulatively); 3) intravenous bisphosphonate at any dose within 5 years prior to Screening visit
- •- PTH or PTH analogues at any dose within 2 years prior to Screening visit
- •- Systemic HRT (oral or transdermal estrogen), SERMs, tibolone, aromatase inhibitors, or calcitonin treatment within 1 year prior to Screening visit
- •- Calcitriol, alfacalcidol, or eldecalcitol within 3 months of the Screening visit
- •- Fluoride or strontium at any dose at any time prior to Screening visit
- •- Romosozumab or cathepsin K inhibitors received at any time prior to Screening visit
- •- Systemic glucocorticoids (>= 5 mg prednisone or equivalent per day for more than 10 days or cumulative >= 50 mg) within 3 months prior to Screening visit
- •- Other bone active drugs such as anticonvulsants, heparin, vitamin K etc. within 3 months prior to Screening visit
- •9. A history and/or presence of significant cardiac disease or ECG abnormalities, or other clinically significant medical conditions indicating significant risk for participating in the study
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