Bone Disease in Chronic Pancreatitis: A Complex Phenomenon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To define the prevalence of low bone density (osteopenia or osteoporosis) in patients with chronic pancreatitis
研究概览
简要总结
The purpose of this study is to define the prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic pancreatitis. Secondary aims include investigating the prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis and determining if hypogonadism and/or use of narcotic pain medications are risk factors for low bone density in this patient population.
- Hypothesis:
Patients with chronic pancreatitis are at increased risk of low bone density (osteopenia/osteoporosis), and hypogonadism (low sex hormone levels) and narcotic pain medication use are independent risk factors for the development of low bone density in this patient population. 2. The outcome measures include:
i) Prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic pancreatitis (as determined by DXA scan and fracture history).
ii) Prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis (as determined by sex hormone levels and clinical history).
iii) Identification of hypogonadism and/or opioid use as risk factors for low bone density in patients with chronic pancreatitis (as determined by univariate and multivariate analysis of multiple risk factors). 3. After obtaining written consent from potential subjects, a questionnaire will be performed outlining risk factors for low bone density. Dual X-ray absorptiometry (DXA scan) will be performed to evaluate for low bone density and a blood test will be performed to evaluate for low sex hormones, low levels of vitamin D, and other risk factors for low bone density.
详细描述
Chronic pancreatitis is defined as a continuing inflammatory disease of the pancreas characterized by irreversible morphologic changes that typically cause pain and/or permanent loss of function. The annual incidence of chronic pancreatitis in the Unites States is 5-12 per 100,000 and prevalence of 50 per 100,000 persons though the incidence is rising over time . The most common symptoms related to chronic pancreatitis include steatorrhea and abdominal pain. Pain with chronic pancreatitis can be severe and debilitating and opioid pain medications are frequently utilized in the management of these symptoms .
A number of chronic malabsorptive disorders, including Crohn's disease, celiac disease, and cystic fibrosis are known to be associated with decreased bone mineral density. Similarly, there is increasing data supporting low bone mineral density (osteopenia and osteoporosis) in patients with chronic pancreatitis, though the exact mechanisms remain unclear.
A meta-analysis of 11 observational studies of chronic pancreatitis reported the prevalence of osteopenia to be 39.8% and osteoporosis 23.4%, with the cumulative prevalence of low bone density (osteopenia and osteoporosis) being almost 65%. Interestingly, out of the eleven studies in this meta-analysis, eight were performed in Europe, two in India, and one in South America.
Some studies in chronic pancreatitis have described a link between Vitamin D deficiency and risk for low bone density. Other proposed risk factors for low bone density in this patient population include age, gender, malnutrition, alcohol use, smoking, and variation and duration of pancreatitis. However, other potential novel risk factors for low bone density exist in patients with chronic pancreatitis. These factors include chronic use of opioid medications and hypogonadism.
Opioid use is prominent in patients with chronic pancreatitis. At least 85% of patients suffering from chronic pancreatitis will develop pain and despite many different treatment methods, many patients with chronic pancreatitis do not get respite from their pain, even after several years. Therefore, up to 50% or more of all patients with chronic pancreatitis will utilize opioid medications as part of their pain management strategy. Opioid medication use has been shown to be a risk factor for low bone density. The exact mechanism behind opioid-induced low bone density is not known but is likely multi-factorial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-75 years
- •Diagnosis of Chronic Pancreatitis, as defined by specific clinical criteria
排除标准
- •Refusal to complete the consent process in it's entirety.
- •Pregnancy
结局指标
主要结局
To define the prevalence of low bone density (osteopenia or osteoporosis) in patients with chronic pancreatitis
时间窗: Single time point (at time of data collection)
Our hypothesis is that there is a high prevalence of low bone density in patients with chronic pancreatitis. We will measure bone density with a bone density (DXA) scan and also obtain fracture history to determine the prevalence of low bone density.
次要结局
- Hypogonadism and/or opioid medication use are independent risk factors for low bone density in patients with chronic pancreatitis.(Single time point (at time of data collection))
- Prevalence of hypogonadism in patients with chronic pancreatitis.(Single time point (at time of data collection))