EUCTR2015-003638-28-DK进行中（未招募）1 期
ALOSTRAAlendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA
Aarhus University Hospital0 个研究点目标入组 160 人开始时间: 2015年8月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients (> 18 years) with rheumatoid arthritis according to the ACR/EULAR (2010) classification criteria (10)
- •-patients must have been treated with oral bisphosphonatesalendronate for 5 years or longer, the last three years with alendronate
- •-current T-score on DXA better than or equal to -2,5 (femoral) and -3,0 (vertebral)
- •-receiving treatment on an outpatient basis
- •-negative pregnancy test (serum HCG) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. Plasma T1/2 of ALN is less than 2 hours. The forms of contraception include: intrauterine device (IUD) and hormonal anticontraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bitalteral tubectomy, hysterectomy and bilateral ooferectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment. Postmenopause will be confirmed by measurement of s-FSH prior to enrollment.
- •-ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- history of hip fracture due to osteoporosis
- •-- history of vertebral fragility fractures within the last three years OR fragility fractures in more than two vertebrae
- •-- history of non-vertebral fragility fractures (fingers and toes not included) within the last three years
- •-osteonecrosis of the jaw.
- •-history of or ongoing systemic GC treatment within the last 6 months (intraarticular injections are approved)
- •-known allergy toward any components of the study medicine
- •-prior or ongoing treatment with with BPs other than ALN or other antiosteoporosis drugs such as hormone replacement therapy (HRT) or teriparatide (low-dose HRT up to 1mg/day is accepted)
- •-evidence of active malignant disease
- •-metabolic bone disease other than osteoporosis
- •-hypo- or hyperthyroidism
- •-hypocalcaemia
- •-impaired renal function (eGFR <35ml/min)
- •-known disease of the esophagus that might impair the ability to swallow the tablets such as achalasia, dysphagia or strictures
- •-history of upper gastrointestinal disease within 1 year prior to enrollment such as peptic ulcer, upper GI bleeding, gastritis, duodenitis or surgical procedures to the upper GI-tract
- •-allergy towards any of the substances in the study medicine
研究者
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