EUCTR2005-003195-38-DE进行中（未招募）1 期
Randomized double-blind placebo-controlled and parallel group study to evaluate the impact of one year therapy with monthly oral ibandronate 150 mg on structural properties of bone in postmenopausal osteoporosis without vertebral fractures - SPIMOS 3D
Center for Muscle and Bone Research of the Charité Universitaetsmedizin Berlin0 个研究点目标入组 62 人开始时间: 2005年9月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
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
- •Age between 60 and 75 years
- •Menopause > 5 years
- •Measurable BMD of the spine and hip by DXA (e.g. no metal devices or severe degenerative changes)
- •BMD of spine (L1 – L4) or hip = -2.0 and > -3.5 SD T-score measured by DXA
- •Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
- •Written informed consent
- •3DpQCT measurable at both skeletal sites, distal tibia and radius
- •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
- •spine or hip BMD = -3,5 SD T-Score measured by DXA
- •Vertebral fractures
- •Multiple (>2) low trauma peripheral fractures
- •Employees of the Centre of Muscle and Bone Research, or their relatives
- •Medical history
- •Disease/disorder known to influence bone metabolism: chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperpara-thyroidism, Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment
- •History of major upper gastro-intestinal (GI) disease
- •Diagnosed malignant disease within the previous 10 years (except successfully resected basal cell cancer)
- •Previous medication
- •Previous treatment with a bisphoshonate at any time
- •Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration)
- •Treatment with PTH and similar agents or strontium ranelate at any time
- •Treatment with other drugs affecting bone metabolism within the last 6 months
- •?Chronic systemic corticosteroid treatment
- •?estrogens, progestins, SERMs, anabolic steroids, active Vit. D analogs/metabolites, calcitonin)
- •?Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
- •Serum total Ca 2+ < 2.2 mmol/l or > 2.6 mmol/l
- •Vitamin D deficiency (serum 25-hydroxy vitamin D < 12 ng/ ml
- •ALT above triple upper limit of normal range
- •Renal impairment (serum creatinine > 210 µmol/l)
- •Contra indications for ibandronate, calcium or vitamin D
研究者
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