EUCTR2006-004738-33-GB进行中（未招募）1 期
Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects. Subtitle: A 2-year randomised parallel group trial of alendronate, ibandronate and risedronate for postmenopausal osteoporosis in secondary care. - TRIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- Female
入选标准
- •at least 5 years post menopausal but <85 years
- •BMD T-score (at the lumbar spine or total hip) of less than -2.5, or T-score less than -1 with a low trauma fracture.
- •be ambulatory
- •be able and willing to participate in the study and provide written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be admitted to the study if they exhibit any of the following:
- •have evidence of a clinically significant organic disease which could prevent the patient from completing the study
- •have a BMI less than 18 or greater than 35
- •abuse alcohol or use illicit drugs
- •have any history of cancer within the past 5 years excluding skin cancer non melanomas
- •have a history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
- •Chronic renal disease (as defined by a creatinine clearance of = 30ml/min)
- •Acute or chronic hepatic disease
- •Malabsorption syndromes
- •Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- •Hyperparathyroidism
- •Hypocalcemia or hypercalcemia
- •Osteomalacia
- •Cushing’s syndrome
- •Patient who are currently on glucocorticoid therapy
- •have a serum calcium less than 2.2 mmol/l and a PTH above 75ng/l
- •have a history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck
- •have markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the Investigator
- •use any of the following medications within 12 months of starting study drug
- •oBisphosphonates (at any dose)
- •oUse of any fluoride with the exception use for oral hygiene
- •oOther bone agents (i.e., SERM, isoflavones etc)
- •have participated in another clinical trial involving active therapy 3 months prior to randomisation
- •have a history of allergic reaction to bisphosphonates
- •patient taking calcium supplements within the last month prior to randomisation
- •We will exclude patients with secondary osteoporosis, those who have been on anti-resorptive treatments in the past year, and women less than 5 years since menopause, and those with bilateral fractures in the measurement regions (heel, hip and forearm).
- •Have suffered a recent fracture within the last 12 months
研究者
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