Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,366
- 试验地点
- 1
- 主要终点
- Proportion of Participants With New Vertebral Fractures
研究概览
简要总结
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of 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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women
- •A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required
排除标准
- •Increased risk of osteosarcoma
- •History of unresolved skeletal diseases that affect bone metabolism
- •History of atypical subtrochanteric or diaphyseal femoral fractures
- •Abnormally high or low calcium levels
- •Abnormally high parathyroid hormone (PTH) levels
- •Severe vitamin D deficiency
- •Abnormal thyroid function not corrected by therapy
- •History of malignant neoplasms in the last 5 years
- •Active liver disease, clinical jaundice
- •Significant impairment of hepatic or renal function
- •History of nephro- or urolithiasis
- •Previous or planned kypho- or vertebroplasty
- •Active or risk for osteonecrosis of the jaw
- •Active or recent history of upper gastrointestinal disorders
- •Unable to stand or sit in the upright position for at least 30 minutes
研究组 & 干预措施
Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Teriparatide (Drug)
Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Placebo (Drug)
Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Calcium (Drug)
Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Vitamin D (Drug)
Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Risedronate (Drug)
Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Placebo (Drug)
Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Calcium (Drug)
Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Proportion of Participants With New Vertebral Fractures
时间窗: Baseline through 24 Months
The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.
次要结局
- Proportion of Participants With Pooled New and Worsening Vertebral Fractures(Baseline through 24 Months)
- Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures(Baseline through 24 Months)
- Proportion of Participants With Major Non-Vertebral Fragility Fractures(Baseline through 24 Months)
- Proportion of Participants With New Moderate and/or Severe Vertebral Fractures(Baseline through 24 Months)
- Proportion of Participants With New Multiple (2 or More) Vertebral Fractures(Baseline through 24 Months)
- Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures(Baseline through 24 Months)
- Proportion of Participants With Non-Vertebral Fragility Fractures(Baseline through 24 Months)
- Change From Baseline to 24 Months Endpoint in Height(Baseline, 24 Months)
- Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale(Baseline, 24 Months)
- Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)(Baseline, 24 Months)
- Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)(Baseline, 24 Months)