NCT05402852Unknown4 期
Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women：A Randomized, Double-blind, Placebo-controlled Trial
Shandong University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The response rate of Quality of life score from baseline
研究概览
简要总结
EuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal women.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign written informed consent and comply with the requirements and restrictions of the test;
- •Female subjects；Age: 45-75 years (including boundary values)；Menopause ≥12 months；Not receiving hormone replacement therapy;
- •Meet the bone reduction criteria: -2.5<T value<-1.0；
- •OSTA index < -1, OSTA index = [body weight (kg) - age (years)] ×0.2;
- •Have the ability of independent activities。
排除标准
- •Patients with abnormalities in lumbar vertebra, hip bone and femoral neck cannot be measured by BMD;
- •Patients with osteoporosis, BMD T-score of the whole hip, femoral neck or lumbar spine ≤-2.5;
- •Have the following diseases known to affect calcium or bone metabolism: various metabolic bone diseases, such as osteogenesis imperfecta, osteomalacia; Paget's disease of bone; Cushing's syndrome; Hyperprolactitinemia; Hypopituitarism; Acromegaly; Rheumatoid arthritis; History of hyperparathyroidism or hypoparathyroidism;
- •Patients who are suffering from or have suffered from osteomyelitis or osteonecrosis of the jaw, or who plan to undergo invasive dental surgery or jaw surgery during the trial, or who have unhealed dental or oral surgery wounds;
- •Fractures in the past 6 months;
- •People with allergic constitution, or known allergy to the test drug ingredients, or a history of allergy to any drug, food or pollen;
- •Randomized prior or plan to use drugs that may affect bone turnover during the study period, including, but not limited to, the following: Used denumab , bisphosphonate or fluoride in the last 12 months, used Contraceptive pills containing estrogen, hormone replacement therapy (e.g., Tibolone, estrogen and selective estrogen receptor modulators, etc.), aromatase inhibitors, calcitonin, strontium salt, parathyroid hormone (or derivative), vitamin D supplements (> 1000 IU/ day), anabolic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsants in the last 6 months; Use inhaled or topical glucocorticoid drugs within 2 weeks;
- •Had significant changes in physical activity within 6 months prior to randomization, or had been engaged in vigorous physical exercise, or planned to participate in vigorous physical exercise during the trial;
- •Hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus antibody (HCV-AB), anti-HIV and anti-treponema pallidum antibody (TP-AB) are positive;
- •Hypocalcemia or hypercalcemia, or serum albumin-corrected serum calcium levels not within the laboratory normal range;
- •After inquiry, the average daily smoking quantity within 3 months prior to randomization ≥5, or can not stop smoking during the trial period;
- •Binge drinking or drinking more than 28 units of alcohol per week (1 unit =350ml beer or 45ml spirits or 150ml wine) within 3 months prior to randomization;
- •Have a history of drug abuse or drug abuse;
- •Complete blood donation, component blood donation, or massive bleeding (>400 ml) within 3 months prior to randomization;
- •Participants in interventional clinical trials of other drugs or devices within 3 months prior to randomization;
- •Suffering from other important primary diseases (such as diseases of the nervous system, cardiovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system) that are not considered suitable for admission, or for other reasons that are not considered suitable for admission;
- •Other factors that the researcher considers unsuitable for inclusion.
研究组 & 干预措施
control：placebo
Placebo Comparator
Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days.
干预措施: placebo (Drug)
Drug：EuBone® capsule
Experimental
Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days.
干预措施: EuBone ® capsule (Drug)
结局指标
主要结局
The response rate of Quality of life score from baseline
时间窗: on day 360 after administration
To evaluate the improvement rate of the Quality of life score from baseline improvement rate
The change of lumbar vertebra bone density
时间窗: on day 360 after administration
To evaluate the change of lumbar vertebra bone density from baseline
The incidence rate of adverse events
时间窗: Through study completion, an average of 360 days
To evaluate the incidence rate of adverse events
次要结局
- The change of serum n-terminal propeptide (S-PINP) and carboxy-terminal cross-linked peptide of type I procollagen (S-CTX) from baseline(at 30, 90, 180 and 360 days after administration)
- The change of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels(at 30, 90, 180 and 360 days after administration)
- The response rate of quality of life score(at 30, 90 and 180 days after administration)
- The change of bone mineral density of lumbar vertebra (L1~L4)(at 180 after continuous administration of EuBone® capsule)
- The change of bone mineral density (BMD) at the total hip joint and femoral neck of the subject(at 180 and 360 days after continuous administration of EuBone® capsule)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University
研究点 (1)
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