NCT00624481撤回2 期
A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density
Nastech Pharmaceutical Company, Inc.0 个研究点目标入组 350 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 350
- 主要终点
- Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
研究概览
简要总结
This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.
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
- — 至 89 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal Female patients up to 89 years, inclusive;
- •BMI ≤ 35 kg/m2, inclusive;
- •In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
- •Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
- •Have a minimum of two evaluable non-fractured lumbar vertebrae.
- •Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip
排除标准
- •Serious Medical Condition
- •History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
- •Have a history of cancer within the past 5 years, except for basal cell carcinoma
- •Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
- •Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.
研究组 & 干预措施
1
Active Comparator
干预措施: Teriparatide (Drug)
2
Experimental
干预措施: Teriparatide Nasal Spray (Drug)
3
Experimental
干预措施: Teriparatide Nasal Spray (Drug)
4
Experimental
干预措施: Teriparatide Nasal Spray (Drug)
5
Experimental
干预措施: Teriparatide Nasal Spray (Drug)
结局指标
主要结局
Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
时间窗: 24 weeks
次要结局
- Change in bone mineral density from baseline to 12 weeks post treatment(12 weeks)
- Safety, including hypercalcemia and nasal effects(24 weeks)
- Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment(4, 12 and 24 weeks)
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