NCT00372099已完成3 期
Evaluation of the Effects of Salmon Calcitonin Nasal Spray Compared to Placebo on Bone Microarchitecture Measured by High Resolution Peripheral Micro- Computed-tomography Over 2 Years in Postmenopausal Women (a Pilot Study)
Rene Rizzoli0 个研究点目标入组 90 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Bone micro-architecture evaluated by high resolution p-QCT
研究概览
简要总结
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot study should provide additional new insights in the mode of action of nasal calcitonin, on structural changes as measured by high resolution peripheral CT, and on the comparison between weight bearing and non weight bearing bones in postmenopausal women.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between age 45-70
- •Natural or surgical menopause ≥ 1 year
- •T-Score between 0.0 and -2.49 (spine or proximal femur - total or femoral neck measured by DXA)
排除标准
- •Osteoporosis (T-score ≤ -2.5 in spine or proximal femur - total or femoral neck, measured by DXA)
- •Severe vertebral fracture, as identified by screening DXA assessment
- •Any history of metabolic disease, which could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, Paget's disease, osteomalacia
- •Thyroid disease (if receiving thyroid hormone replacement, the patients must be euthyroid, and on a stable dose of thyroid hormone)
- •Impaired renal function (estimated GFR<30 ml/min)
- •History of previous or active malignancy of any organ system, treated or not treated within the past 5 years.
- •History of corticosteroids treatments during 6 months or more, daily dosage >5 mg .
- •BMI < 18 or >
- •Treatments with estrogens, SERMs, tibolone, calcitonin, strontium ranelate, teriparatide or PTH, oral or iv bisphosphonates in the previous year.
结局指标
主要结局
Bone micro-architecture evaluated by high resolution p-QCT
时间窗: 24 months
次要结局
- Bone turn-over markers(24 months)
研究者
Rene Rizzoli
Professor
University Hospital, Geneva
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