Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline to 18 Months in Lumbar Spine BMD
研究概览
简要总结
The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis.
- •Ambulatory, 5 years or more past menopause.
- •BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
- •Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.
排除标准
- •Prior treatment with PTH or a PTH analogue.
- •Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
- •History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
- •History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
- •Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.
- •Nephrolithiasis or urolithiasis within 2 years, or impaired renal function.
- •Abnormal uncorrected thyroid function.
- •Liver disease or clinical jaundice.
- •Alcohol or other drug abuse.
- •Poor medical or psychiatric risk for treatment.
研究组 & 干预措施
Teriparatide
20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.
干预措施: Teriparatide (Drug)
Teriparatide
20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.
干预措施: Calcium (Dietary Supplement)
Teriparatide
20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.
干预措施: Vitamin D (Dietary Supplement)
Teriparatide
20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.
干预措施: Placebo-Oral (Drug)
Alendronate
10 milligrams/day alendronate orally plus SC injection placebo for 18 months.
干预措施: Alendronate (Drug)
Alendronate
10 milligrams/day alendronate orally plus SC injection placebo for 18 months.
干预措施: Calcium (Dietary Supplement)
Alendronate
10 milligrams/day alendronate orally plus SC injection placebo for 18 months.
干预措施: Vitamin D (Dietary Supplement)
Alendronate
10 milligrams/day alendronate orally plus SC injection placebo for 18 months.
干预措施: Placebo-SC (Drug)
结局指标
主要结局
Percent Change from Baseline to 18 Months in Lumbar Spine BMD
时间窗: Baseline, 18 Months
次要结局
- Percent Change from Baseline in Total Hip and Femoral Neck BMD(Baseline, 12 Months, 18 Months)
- Percent Change from Baseline in Lumbar Spine BMD(Baseline, 3 Months, 6 Months, 12 Months)
- Percent Change from Baseline in Cortical BMD at the Femoral Neck(Baseline, 6 Months, 18 Months)
- Percent Change from Baseline in Trabecular BMD at the Femoral Neck(Baseline, 6 Months, 18 Months)
- Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine(Baseline, 6 Months, 18 Months)
- Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP)(Baseline, 1 Month, 3 Months, 6 Months, 12 Months)
- Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP)(Baseline, 1 Month, 3 Months, 6 Months, 12 Months)
- Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)(Baseline, 1 Month, 3 Months, 6 Months, 12 Months)
- Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)(Baseline, 1 Month, 3 Months, 6 Months, 12 Months)
- Percentage of Participants with Nonvertebral Fractures(18 Months)
- Percentage of Participants with Clinical Fractures(18 Months)
- Change from Baseline on the Back Pain Questionnaire(Baseline, 3 Months, 6 Months, 18 Months)