NCT00693667已完成2 期
A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Biochemical Markers
研究概览
简要总结
The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis.
The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 40-60 years of age.
- •Must be postmenopausal (0.5~5 years post cessation of menses) or ovariectomized or hysterectomy women who have documented elevated Follicle Stimulating Hormone FSH (>30mIU/ml) with low serum estradiol (<20 pg/ml).
- •The lumbar vertebral BMD T-score is between -1and -2.5 SD.
- •The body mass index (BMI) is between 19 and 29 kg/m
- •Completed informed consent and signed informed consent form.
排除标准
- •Have diseases which may affect bone metabolism, e. g., hyper-or hypocalcemia, hyperthyroidism, osteogenesis imperfecta, malignancy, chronic gastrointestinal disease, extensive Paget's disease, alcoholism, and renal or hepatic impairment.
- •Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.
- •Chronic or continued use of hormone replacement drugs or medications that may affect bone calcium metabolism, for example, phosphate-binding antacids, many diuretics, adrenal or anabolic steroids, heparin, anticonvulsants, fluoride in excess of 1 mg/day and supplements of vitamin D or A in excess of RDAs.
- •Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL ~ 66.1 pg/mL).
- •Patients with fracture history.
- •Patients who can not promise to keep from taking stimulant drinks (for example, coffee, tea, alcoholic drink, and Coke) that may cause loss of bone calcium, during the study period.
研究组 & 干预措施
A
Placebo Comparator
Placebo
干预措施: PH3 (Drug)
B
Active Comparator
250 mg active ingredient
干预措施: PH3 (Drug)
C
Active Comparator
500 mg active ingredient
干预措施: PH3 (Drug)
D
Active Comparator
750 mg active ingredient
干预措施: PH3 (Drug)
结局指标
主要结局
Biochemical Markers
时间窗: four weeks
次要结局
- Bone Densitometry(four weeks)
研究者
研究点 (1)
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