ISRCTN32813419
已完成
2 期
Phase II study of the impact of AZD4017, a selective 11bHSD1 inhibitor, on biochemical markers of bone turnover in post-menopausal osteopaenia
niversity of Leeds0 个研究点目标入组 55 人2015年5月20日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoporosis
- 发起方
- niversity of Leeds
- 入组人数
- 55
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
2020 Abstract results in https://doi.org/10.1530/endoabs.70.AEP130 (added 23/04/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35275196/ (added 07/12/2022)
研究者
入排标准
入选标准
- •Current inclusion criteria as of 21/06/2017:
- •1\. Provision of informed consent prior to any study specific procedures
- •2\. Aged \>50 and post\-menopausal based on amenorrhoea for \>12 months
- •3\. Documented presence of osteopenia (BMD T\-score at lumbar spine and/or total hip of less than or equal to \-1 and greater than \-2\.5\) as measured by DXA
- •4\. Placebo treatment for the duration of the study must not be considered detrimental to the study participant
- •5\. Must be able to understand the patient information sheet and consent form and comply with study requirements
- •Previous inclusion criteria:
- •1\. Provision of informed consent prior to any study specific procedures
- •2\. Aged \>50 and postmenopausal based on amenorrhoea for \>12 months
- •3\. Documented presence of osteopaenia (bone density T\-score at lumbar spine or hip of less than \-1 and greater than \-2\.5 by Dual\-energy X\-ray Absorptiometry (DXA) criteria)
排除标准
- •Current exclusion criteria as of 21/06/2017:
- •Bone\-related exclusion criteria:
- •1\. Clinical or biochemical evidence of secondary causes of bone loss (screening tests to include but are not restricted to: normal serum sodium, potassium, urea, creatinine (eGFR at \>60 mls/min), LFTs, ALP, TFTs; free T4 and TSH), FBC and ESR (\<40mm/hr))
- •2\. Vitamin D deficiency (defined as a 25\-OH vitamin D level of \<20nmol/L)
- •3\. The current or recent use (within the last 2 years) of medication likely to have an impact on bone (oestrogens, aromatase inhibitors, bisphosphonates, fluoride, denosumab, strontium ranelate, anti\-convulsants; and oral, inhaled or nasal glucocorticoids). Participants already on calcium/vitamin D supplementation will be asked to continue this for the duration of the study. Those with a 25\-OH vitamin D level of 20\-50nmol/L at screening will be supplemented prior to inclusion. Medications will be reviewed at the screening visit
- •4\. Bilateral fractures of the radius and/or tibia
- •General exclusion criteria:
- •1\. Women of child\-bearing potential (WOCBP). Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea\= 12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level \>35 mIU/mL)
- •2\. Have an estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (GFR calculation) using theMDRD equation of \<60ml/min/1\.73m2
- •3\. Have any endocrine disorder that would merit therapy according to national guidelines. The only exception to this is patients with hypothyroidism on treatment with thyroid function tests within normal parameters for a minimum of 3 months
结局指标
主要结局
未指定
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