The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint
研究概览
简要总结
The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.
详细描述
As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 (after the "change of life") women with osteoporosis
- •between the ages of 45-85
- •have low bone mass as determined by a bone density test
- •have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
- •could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate
排除标准
- •have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
- •have a metal implant or have had a hip replacement in either hip which might affect results of study
- •have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
- •currently have active or suspected diseases that affect the bone, other than osteoporosis
- •have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values
研究组 & 干预措施
Teriparatide
20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
干预措施: teriparatide (Drug)
结局指标
主要结局
Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint
时间窗: Baseline, 18 months
SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.
次要结局
- Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint(Baseline, 18 months)
- Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint(Baseline, 24 months)
- Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint(Baseline, 18 months)
- Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint(Baseline, 18 months)
- Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint(Baseline, 18 months)
- Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint(Baseline, 3, 6, 24 months)
- Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint(Baseline, 3, 6, 24 months)
- Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint(Baseline, 3, 6, 12, 18, 24 months)
- Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint(Baseline, 18, 24 months)
- Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint(Baseline, 18, 24 months)