Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.
研究概览
简要总结
Background:
- Osteoporosis is a condition where the bone becomes more brittle and more likely to break as a person ages. The drugs that people take to treat this condition have prevented many common hip fractures. But these drugs may be associated with problems in the shape and structure of the hip bone after many years of use. These changes in the hip bone may lead to an unusual kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers want to learn more about these fractures.
Objectives:
- To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for several years, those who have just started taking them, and those who have never taken these drugs.
Eligibility:
- People at least 50 years of age who have been taking osteoporosis drugs for at least 5 years.
- People at least 50 years of age who have been taking these drugs for less than 1 year.
- People at least 50 years of age who have never taken these drugs.
Design:
- All participants will have three total visits over 3 years.
- At the first visit, those taking part will have a medical history and physical exam. They will complete a questionnaire about medication use and bone health. They will also have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to test for osteoporosis) of the hips.
Those in the study will repeat these exams and medical history questions at followup visits. These visits will take place 18 months and 36 months after the first study visit.
- At any of these visits, participants who may have a hip fracture that does not show up on the x-rays will have an imaging study to examine the bone more closely.
- Participants who receive a hip replacement or suffer from a broken bone at any time should inform the study researchers as soon as possible.
详细描述
Objective:
Bisphosphonates are a class of medications that treat osteoporosis and prevent fractures, and have been available for more than a decade. However, there have been recent studies that have shown that, on rare occasions, they may be associated with an atypical hip fracture after long-term use. Radiographic features such as beaking and thickening along the side of the hip bone have been frequently observed with these atypical femur fractures, but most of the studies to date have only been focused on finding the fractures, not the x-ray features. It is not known how common these x-ray features and pain symptoms are amongst bisphosphonate users that have not yet experienced a fracture. If there is a difference between users and non-users, these features may be a valuable finding to help catch fractures before they happen. A recent hypothesis has emerged that a genetic condition, hypophosphatasia, may play a role.
Study population:
This study will evaluate the presence of these features in users of bisphosphonates and the general population. Individuals from the community who have taken bisphosphonates for five or more years (and still taking or have since stopped) will be compared with individuals recently starting bisphosphonate treatment and individuals without osteoporosis and not taking bisphosphonates but similar in age. Another cohort of patients who have sustained atypical femur fractures will also be recruited.
Design:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.
次要结局
- Difference in rates of cortical thickening over three years between long term users vs. short term or nonusers of bisphosphonates.
- Difference in rates of subtrochanteric fractures over three years between long term users vs. short term or nonusers of bisphosphonates.