NCT00271713已完成4 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- BV/TV and trab. Sp. measured by 3D pQCT device
研究概览
简要总结
Efficacy:
To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.
Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT.
Safety:
To assess the tolerability and safety of ibandronate therapy
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 60 and 75 years
- •Menopause > 5 years
- •Spine (L1 - L4) or hip BMD ≤ -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
排除标准
- •Spine or hip BMD ≤ -3,5 SD T-Score measured by DXA
- •Vertebral fractures
- •Multiple (>2) low trauma peripheral fractures
- •Disease/disorder known to influence bone metabolism
- •History of major upper gastro-intestinal (GI) disease
- •Diagnosed malignant disease within the previous 10 years
- •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 vitamin D analogues/metabolites, calcitonin
- •Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
- •Total serum calcium < 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
- •Employees of the Centre for Muscle and Bone Research, or their relatives
研究组 & 干预措施
ibandronate
Active Comparator
150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
干预措施: ibandronate, calcium and vitamin D (Drug)
2
Placebo Comparator
placebo monthly plus 500mg calcium and 800 UI vitamin D daily
干预措施: placebo,calcium and vitamin D (Drug)
结局指标
主要结局
BV/TV and trab. Sp. measured by 3D pQCT device
时间窗: Baseline and after 3, 6, 9 and 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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