12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)
研究概览
简要总结
The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment.
This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.
详细描述
This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent study to be treated for a second year and will allow those individuals who received teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy. This study will determine if two years of exposure to teriparatide will result in a greater increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects will be evaluated at 6 and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury".
- •Adherence rate for teriparatide use of ≥60%.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Individuals who could not tolerate teriparatide treatment.
- •Individuals who will not be able to return for all study visits.
- •Patients may not be receiving any other investigational agents.
- •Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
研究组 & 干预措施
Teriparatide and vibration
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
干预措施: Teriparatide (Drug)
Teriparatide and vibration
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
干预措施: Vibration (Device)
结局指标
主要结局
Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)
时间窗: Baseline to 24 months
The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
次要结局
- C-terminal Telopeptide(Baseline to 24 Months)
- Bone Mineral Density (BMD) by DXA at the Lumbar Spine(Baseline to 24 Months)
- Bone Mineral Density (BMD) by DXA at Femoral Neck(Baseline to 24 Months)
- Amino-terminal Propeptide of Type 1 Collagen(Baseline to 24 Months)
- Bone-specific Alkaline Phosphatase(Baseline to 24 Months)
研究者
Thomas J. Schnitzer
Professor
Northwestern University