TCTR20190815001已完成1 期
The effect of Cissus quadrangularis L. capsule on delaying bone loss in postmenopausal women with osteopenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 134
研究概览
简要总结
After 24 weeks of treatment, the CQ1.2 and CQ1.6 showed no effect on BMD change at lumbar spine, femoral neck, and total hip. However, The CQ 1.6 g/day showed to stabilized CTX and significantly decreased serum P1NP. This indicated the promising effect of CQ on delaying bone loss by decrease in the bone remodeling process. The safety of CQ 1.2, and 1.6 g/day for 24 weeks were comparable to the placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 Years 至 70 Years（—）
- 性别
- Female
入选标准
- •(1) The postmenopausal women aged more than 40 years old
- •(2) Participant with 1 -10 years since menopause
- •(3) Participant with estradiol less than 35 pg/mL and
- •(4) Participant with FSH more than 30 mIU/mL
- •(5) Participant with osteopenia at lumbar spine, femoral neck, or total hip
排除标准
- •(1) Participant with underlining disease that affects to bone remodeling process, e.g., thyroid disorder, parathyroid disorder, rheumatoid arthritis
- •(2) Receiving medications that affect bone metabolism, e.g., glucocorticoid, anticoagulation, anticonvulsant, steroid, immunosuppressive agent, antiepileptic, aromatase inhibitor, GnRH antagonist, SSRI, thiazolidinedione, calcineurin inhibitor, and chemotherapy
- •(3) serum AST more than 40 U/L
- •(4) serum ALT more than 40 U/L
- •(5) serum creatinine more than 1.3 or less than 0.4 mg/dL
- •(6) eGFR less than 60 ml/min per 1.73 m2
- •(7) Participant with a history of decreasing height more than 4 cm
- •(8) Participant with a 10-year probability of hip fracture more than 3% or other major osteoporotic fractures more than 20%
研究者
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