PACTR202407466904092Other3 期
A Randomized, Double Blind, Single Centre, study to assess the efficacy, safety and tolerability of the Gastrin Receptor Antagonist (GRA), Netazepide administered for 90 days, in post-menopausal women (OSTEO-GRA)
niversity of Cape Town0 个研究点目标入组 90 人开始时间: 2024年3月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 90
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
- 45 Year(s) 至 64 Year(s)（—）
- 性别
- Female
入选标准
- •A participant must meet the following criteria to be eligible for inclusion in the study:
- •1.Women >5 years post-menopausal or who have had an oophorectomy
- •2.FSH levels of >40 IU/L (the FSH level precludes premenopausal women and those who may have FSH-related bone losses) as determined at the screening visit.
- •3.Participants with no clinical or biochemical evidence of secondary causes of bone loss (Appendix 1).
- •4.Participants must not be taking medications (see Appendix 6) that have an action on bone metabolism
排除标准
- •A participant who meets any of the following criteria will be excluded from the study:
- •1.Participants with confirmed diagnoses according to their medical history from diseases with a known propensity to result in secondary bone loss that might cloud the assessment of disease naïve osteoporosis. It includes Diabetes Mellitus, thyroid dysfunction (TSH outside the reference range), IBD, celiac disease, pancreatic exocrine insufficiency, epilepsy, hyperparathyroidism. (Appendix 1)
- •2.Participants who have had a bone fracture in the previous year. (Appendix 1)
- •3.Participants who have had orthopaedic surgery in the previous year. (Appendix 1)
研究者
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