NCT00343252已完成3 期
The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
研究概览
简要总结
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women 45 years or older. No period for at least two years.
- •History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
- •Minimum of one moderate spinal bone fracture.
- •Beginning pain level of at least four on an eleven point scale.
- •Bone Mineral Density (BMD) must meet criteria
- •Able to read, understand, and administer self-questionnaires.
- •Be willing and able to use a pen-injector to deliver the medication.
排除标准
- •Are at increased risk for osteosarcoma.
- •Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
- •Participants that already know that they will require procedures to repair their spinal bone fractures.
- •Abnormal values of certain lab tests.
- •Anything that would make it difficult to determine if the back pain was due to the fracture.
- •Poor medical or psychiatric condition.
- •Alcohol or drug abuse within a year of the study start.
- •Certain malignant neoplasms in the 5 years prior to enrollment.
- •Active liver disease or clinical jaundice.
- •Significantly impaired renal function.
- •History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
- •Known contraindication or intolerance to risedronate and/or teriparatide therapy.
- •Treatment with oral strontium or certain therapeutic doses of fluoride.
研究组 & 干预措施
Risedronate
Active Comparator
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
干预措施: risedronate (Drug)
Teriparatide
Experimental
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
干预措施: teriparatide (Drug)
Teriparatide
Experimental
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
干预措施: placebo (Drug)
Risedronate
Active Comparator
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
时间窗: 6 Months
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
次要结局
- Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint(6 Months)
- Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months(Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300)
- Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint(12 Months)
- Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint(12 Months)
- Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months(Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600)
- Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months(Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300)
- Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months(Baseline through 18 Months)
- Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.(Baseline, 18 Months)
- Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months(Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600)
- Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.(Baseline, 3 Months)
- Number of Participants With Adverse Events (Safety) During 18 Months(Baseline through 18 Months)
- Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint(18 Months)
- Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)(Baseline, 12 Months)
- Number of Participants With Adverse Events (Safety) During 12 Months(Baseline through 12 Months)
- Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)(Baseline, 18 Months)
- Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.(Baseline, 6 Months)
- Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.(Baseline, 12 Months)
- Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint(18 Months)
- Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)(Baseline, 6 Months)
- Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months(Baseline through 18 Months)
研究者
研究点 (1)
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