EUCTR2009-011888-37-DE进行中（未招募）不适用
A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT
ovartis Pharma GmbH0 个研究点开始时间: 2010年3月26日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Written informed consent to participate in the trial
- •2) Males and Females between 18 and 75 years of age
- •3) Definite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria (Appendix 3)
- •4) MS-subtype: RRMS, SPMS, PPMS
- •5) EDSS score between 2.5 to 6.5 (including)
- •6) No immunomodulatory treatment for MS within the last 30 days or stable and well tolerated therapy with any beta-interferon formulation, glatirameracetate or fingolimod for at least 30 days immediately prior to baseline.
- •7) BMD T-score of less or equal to -2.0 but not less or equal to -4.0 at the lumbar spine (L1-L4 with at least 2 evaluable vertebrae) and/or total hip region and/or femoral neck in recent DXA-scan (= 3 months). The DXA-scans for all assessments need to be performed with the same DXA-machine.
- •8) Previous participation in CZOL446HDE39
- •9) 25-OH vitamin D level greater or equal to 15 ng/ml
- •10) Sufficient ability to read, write and communicate comprehensibly and comply to study procedures
- •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
- •1) Contraindications against Calcium and Vitamin D according to the summary product characteristics
- •2) Contraindications against zoledronic acid according to the summary of product characteristics
- •3) Hypersensitivity to bisphosphonates, Calcium and Vitamin D or to drugs with similar chemical structures
- •4) More than one osteoporotic fracture
- •5) Severe disability or any clinical impairment that can prevent the patient to meet all study requirements
- •6) Concomitant medication with influence on bone mineral density (eg. enzyme-inducing antiepileptics like Carbamazepin, Phenytoin, Phenobarbital, Primidon)
- •7) Any neurological disorder other than MS which is known to affect bone mineral density (e.g. muscular dystrophy, severe paresis due to other reasons than MS, degenerative nervous disorder, stroke)
- •8) Any bone disorder other than osteoporosis known to affect bone mineral density (e.g. paget´s disease, osteogenesis imperfecta, multiple myeloma)
- •9) Study personnel or first degree relatives of investigator(s) must not be included in the study.
- •10) Women who are
- •- pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mlU/ml)).
- •- menstruating and capable of becoming pregnant* and not practicing two medically approved methods of contraception (Pearl Index < 1**) during and up to at least one year after the end of treatment. A negative pregnancy test (serum) for all women is required with sufficient lead time before inclusion.
- •*definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level > 40 mlU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
- •**examples of particularly reliable methods with Pearl Index (PI) < 1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe:
- •Combination pill with estrogen and gestagen (no minipill, PI=0.1-0.9)
- •Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr.)
- •Contraceptive patch (EVRA®, PI=0.72 uncorr.; 0.9 corr.)
- •Estrogen-free ovulation inhibitors (Cerazette®, PI=0.14)
- •Progestin-containing contraceptives (Implanon®, PI=0-0.08)
- •Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
- •Intra-uterine progestine device (Mirena®, PI=0.16)
- •11) Baseline renal insufficiency (calculated creatinine clearance less than 35.0 mL/min); Urine dipstick greater than or equal to 2+ protein at Visit 1 without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination).
- •12) Pre-existing hypocalcemia = 2.0 mmol/L (8.0 mg/dL) not adequately treated by intake of calcium and vitamin D before baseline
- •13) Use of testosterone therapy within one year prior to randomization
- •14) Use of systemic corticosteroids (oral or i.v.) in the last year with more than 7.5 mg/day prednisolone (or equivalent) continuously for more than four weeks.
- •NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (eg. intra-articularly, ocular, intrsthecal) or pulsed therapy for MS-relapses are NOT exclusionary.
- •15) Prior exposure to anabolic steroids or growth hormone within 6 months prior to randomization
- •16) Treatment with any investigational drug(s) and/or devices within 30 days prior to randomization.
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