Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone Mass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Bone Mineral Density
研究概览
简要总结
A randomized, double-blind, placebo-controlled trial including 160 consecutive patients who have been diagnosed with both rheumatoid arthritis (RA) and low bone mass and have been treated with alendronate (ALN) for five years or more. Patients will be randomized to discontinuation or continuation of alendronate. Outcomes are measured using dual energy absorptiometry (DXA), High Resolution peripheral Quantitative Computer Tomography (HR-pQCT) and biochemical markers of bone metabolism and inflammation after 6 months, 1 and 2 years.
详细描述
Primary objectives:
- to assess the effect of discontinuation of alendronate (ALN) on C-terminal telopeptide crosslinks (CTX) and Type 1 procollagen amino-terminal-propeptide (P1NP) after 6 months
- to assess the effect of discontinuation of ALN on bone mineral density (BMD) on DXA scans at 2 years
Secondary objectives:
- to assess the effect of discontinuation of ALN on vBMD on HRpQCT scans at 2 years
- to assess the effect of discontinuation of ALN on biochemical markers of bone metabolism after 6 and 24 months
- to evaluate and compare the changes in vBMD in cancellous and cortical bone respectively, after discontinuation of ALN
- to evaluate the correlation between RA activity measured by DAS28-CRP and bone metabolism
Interventions:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (> 18 years) with rheumatoid arthritis according to the ACR(1987 or 2010)/EULAR (2010) classification criteria (12)
- •treated with alendronate for five years or more
- •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 / bilateral tubectomy, hysterectomy and bilateral oophorectomy) 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.
排除标准
- •history of hip fracture due to osteoporosis
- •history of vertebral fracture of more than one vertebrae or other fragility fractures within the last three years (fingers and toes not included)
- •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 other antiosteoporosis drugs such as hormone replacement therapy or teriparatide
- •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
研究组 & 干预措施
Alendronate
Continues treatment with alendronate, 70mgs oral tablet once every week
干预措施: Alendronate (Drug)
Alendronate
Continues treatment with alendronate, 70mgs oral tablet once every week
干预措施: Calcium (Drug)
Alendronate
Continues treatment with alendronate, 70mgs oral tablet once every week
干预措施: Vitamin D (Drug)
Placebo
Placebo tablets, one every week
干预措施: Placebo (Drug)
Placebo
Placebo tablets, one every week
干预措施: Calcium (Drug)
Placebo
Placebo tablets, one every week
干预措施: Vitamin D (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: Change from baseline to 24 months
C-terminal telopeptide crosslinks (CTX)
时间窗: Change from baseline to 6 months
serological marker of bone metabolism
Type 1 procollagen amino-terminal-propeptide (P1NP)
时间窗: Change from baseline to 6 months
serological marker of bone metabolism
次要结局
未报告次要终点