B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Number of Subjects With Forteo B Pen Complaints at 8 Weeks
研究概览
简要总结
This study is being conducted to collect information from subjects with osteoporosis regarding their experience using the Forteo B Pen to self-administer teriparatide in the community setting. Information collected during this study will be used to assess the need for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the information generated from patients during this trial will be reviewed to assess the acceptability of the Forteo B Pen for commercial launch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men with primary or hypogonadal osteoporosis or postmenopausal women with osteoporosis in the opinion of the investigator. Subjects must be at high risk for fracture in the opinion of the investigator.
- •Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel.
- •Able to read, understand, and respond to self-administered questionnaires.
- •Without language barrier, cooperative, and expected to return for all follow-up procedures.
- •Have provided written informed consent to participate in this study, according to local regulations after being informed of the risks, medications, and procedures to be used in the study.
排除标准
- •Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.
- •Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.
- •Subjects who have an increased baseline risk of osteosarcoma, including those with: Paget's disease of the bone or unexplained elevations of alkaline phosphatase, children and young adults with open epiphyses, and subjects who have received external beam or implant radiation therapy involving the skeleton.
- •History of malignant neoplasms in the 5 years prior to study entry, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated, or history of carcinoma in situ of the cervix or uterus.
结局指标
主要结局
Number of Subjects With Forteo B Pen Complaints at 8 Weeks
时间窗: 8 weeks
Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Summary of Forteo B Pen Complaints at 46 Weeks
时间窗: 46 weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Number of Subjects With Forteo B Pen Complaints at 46 Weeks
时间窗: 46 weeks
Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Summary of Forteo B Pen Complaints at 8 Weeks
时间窗: 8 weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
次要结局
- Summary of Subject Preference Assessments - Overall Preference(4 weeks)
- Summary of Subject Preference Assessments - Learning to Use the Pen(4 weeks)
- Summary of Subject Preference Assessments - Attaching a New Needle(4 weeks)
- Summary of Subject Preference Assessments - Setting the Dose(4 weeks)
- Summary of Subject Preference Assessments - Injecting a Dose(4 weeks)
- Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose(4 weeks)
- Summary of Subject Preference Assessments - Assurance That Drug is Delivered(4 weeks)
- Summary of Subject Preference Assessments - Removing a Used Needle(4 weeks)
- Summary of Subject Preference Assessments - Overall Ease of Use(4 weeks)
- Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen(4 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Read Label(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap(8 weeks)
- Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose(8 weeks)
- Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - Reusing Needles(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle(8 weeks)
- Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use(8 weeks)