NCT05902078招募中4 期
Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Shanghai Jiao Tong University Affiliated Sixth People's Hospital21 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年9月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 21
- 主要终点
- Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
研究概览
简要总结
To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.
详细描述
Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal.
- •BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:
- •low BMD: -2.5<T< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history
- •Ambulatory outpatients
- •Written informed consent
排除标准
- •Severe vitamin D deficiency at screening (defined as serum 25OHD<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened
- •Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry
- •Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate oral for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
- •Urolithiasis at screening
- •Hypercalcemia (serum calcium >10.4 mg/dL), or hypercalciuria (urine calcium>400 mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women)
- •Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
- •Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
- •History of allergy to vitamin D
- •Any condition which in the opinion of the investigator unfit for the study
研究组 & 干预措施
Eldecalcitol
Experimental
Participants receive oral eldecalcitol 0.75μg daily for 12 months
干预措施: Eldecalcitol capsules (Drug)
Calcitriol
Active Comparator
Participants receive oral calcitriol 0.5μg daily for 12 months
干预措施: Calcitriol capsules (Drug)
结局指标
主要结局
Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
时间窗: Baseline to 12 months
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
次要结局
- Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)(Baseline and months 6 and 12)
- Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine(Baseline to 6 months)
- Percent Change From Baseline at Month 6 in BMD of the Total Hip(Baseline to 6 months)
- Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)(Baseline and months 6 and 12)
- Percent Change From Baseline at Month 6 in BMD of the Femoral Neck(Baseline to 6 months)
- Percent Change From Baseline at Month 12 in BMD of the Total Hip(Baseline to 6 months)
- Percent Change From Baseline at Month 12 in BMD of the Femoral Neck(Baseline to 12 months)
- Percent Change From Baseline in Parathyroid Hormone (PTH)(Baseline and months 6 and 12)
- Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D](Baseline and months 6 and 12)
- Incidence of new vertebral fracture(Baseline and months 12)
研究者
Zhenlin Zhang, MD
Chief Physician
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
研究点 (21)
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