Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Procollagen type 1 N-terminal propeptide (P1NP)
研究概览
简要总结
Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and an oral glucose tolerance test is performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18-50 years.
排除标准
- •Uncontrolled thyrotoxicosis
- •Chronic kidney disease (eGFR <30)
- •Known Cushing's syndrome
- •Previous gastric bypass and/or known ongoing malabsorption
- •Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
- •Use of oral or inhaled glucocorticoids within the past year
- •Menopause (defined as 1 year without menstrual bleeding)
- •Pregnancy (defined as elevated HCG)
- •Ongoing infection
- •Allergy to prednisolone or one of the excipients
- •Systematic fungal infections
- •Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination
- •Not able to provide informed consent (e.g., dementia, not able to understand Danish).
研究组 & 干预措施
Prednisolone group
干预措施: Prednisolone (Drug)
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Procollagen type 1 N-terminal propeptide (P1NP)
时间窗: Baseline to day 8
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8
次要结局
- Bone tissue(Baseline to day 8)
- Collagen 1 cross link C-terminal telopeptide (CTX)(Baseline to day 8 and 15)
- P1NP (baseline to day 15)(Baseline to day 15)
- Concentration of Glucocorticoid metabolites(Baseline to day 8)
- Adipose tissue(Baseline to day 8)
- Glucose(Baseline to day 8)
- C-peptid(Baseline to day 8)