EUCTR2005-000730-20-GB进行中（未招募）1 期
An open label, international, multi centre, parallel group, phase III b, randomised trial, investigating lumbar spine Bone Mineral Density (BMD) changes in postmenopausal women with primary osteoporosis initially treated with 12 months of full length parathyroid hormone (PTH 1-84) followed by 12 months of treatment with risedronate followed by either 12 months treatment with PTH (1-84) or risedronate. - Sequential treatment of postmenopausal women with primary osteoporosis
ycomed Denmark Aps0 个研究点目标入组 390 人开始时间: 2005年12月20日最近更新:
适应症
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
- 390
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
入选标准
- •All inclusion criteria must be answered yes for a subject to be enrolled in the trial.
- •1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
- •2. Is the subject above 50 years old?
- •3. Is the subject postmenopausal (more than 5 years) – in the judgement of the investigator?
- •4. Does the subject have primary osteoporosis with a lumbar spine T score equal to or less than -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
- •5. Does the subject have a life expectancy of >3 years?
- •6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
- •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
- •All exclusion criteria must be answered no for a subject to be enrolled in the trial.
- •1. Is the subject currently in treatment with Selective Estrogen Receptor Modulators (SERMs) (e.g. raloxifen)? If the SERM treatment is terminated the subject can still be evaluated for eligibility.
- •2. Has the subject ever been treated with any bisphosphonate other than alendronate or risedronate?
- •3. Has the subject been treated with alendronate or risedronate for more than 3 years in total?
- •4. Has the subject during lifetime been treated with both alendronate and risedronate, including sequential treatment?
- •5. Has the subject during lifetime been treated with strontium > 3 months in total?
- •6. Has the subject during lifetime been treated with fluoride > 3 months in total?
- •7. Has the subject during lifetime been treated with teriparatide or PTH (1-84)?
- •8. Has the subject during lifetime been treated with calcitonin during the last 3 months?
- •9. Is the subject currently receiving antiepileptic medication?
- •10. Does the subject take any other medication, that according to investigator’s opinion, is known to affect bone metabolism?
- •11. Has the subject received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to:
- •5.0mg prednisolon or equivalent daily for 3 months during the last year or
- •2.5mg prednisolon or equivalent daily for 6 months during the last year
- •12. Has the subject ever received radiation therapy to the skeleton?
- •13. Has the subject been treated for cancer (other than basocellular skin cancer) within the last 5 years?
- •14. Has the subject ever had malignant disease affecting the skeleton?
- •15. Has the subject ever had breast cancer?
- •16. Does the subject have any known clinically significant diseases affecting calcium metabolism?
- •17. Does the subject have any known history of metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, Paget’s disease, osteogenesis imperfecta, or osteomalacia)?
- •18. Does the subject have a medical history of abnormalities in oesophagus prohibiting emptying of oesophagus (e.g. achalasia or stricture) and inability to ingest risedronate (should be able to take risedronate upright) judged by the investigator to be significant?
- •19. Does the subject have any known history of hypersensitivity to parathyroid hormone or risedronate or any of the excipients in the products?
- •20. Does the subject have any clinically significant conduction abnormalities e.g. second degree atrial ventricular block as assessed by the investigator based on ECG reading?
- •21. Does the subject have a plasma 25-hydroxyvitamin D level <9.2ng/ml after at least 14 days of calcium and vitamin D supplementation?
- •22. Does the subject have a plasma PTH of > 65pg/ml and a total serum calcium value >2.49 mmol/l?
- •23. Does the subject have hypercalcaemia (total serum calcium value >2.55mmol/l) after at least 14 days of calcium supplementation?
- •24. Does the subject have a clinically significant elevation of serum alkaline phosphatase
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