Guidelines for screening, prophylaxis and critical information prior to initiating anti-TNF-alpha treatment.

These national clinical guidelines outlining the screening, prophylaxis and critical information required prior to initiating anti-TNF-alpha treatment have been approved by the Danish Society for Gastroenterology. Anti-TNF-alpha therapy is widely used in gastroenterology (for inflammatory bowel disease), rheumatology (for rheumatoid arthritis, psoriatic arthritis and spondyloarthropathies) and dermatology (for psoriasis). With this background, the Danish Society for Gastroenterology established a group of experts to assess evidence for actions recommended before treatment with anti-TNF-alpha agents. Screening should take place for both active tuberculosis and latent tuberculosis. Screening must evaluate the risk of hepatitis B exposure/infection and that of other viral infections such as human immunodeficiency virus (HIV) and varicella zoster virus (VZV). The assessment should include a history of previous malignancies (cases of malignant disease within 5 years of anti-TNF-alpha treatment should be carefully considered). The physical examination should include lung/heart auscultation and lymph node examination, and the paraclinical investigations should include chest X-rays and laboratory tests, including an interferon gamma release assay, a hepatitis B test, an HIV test and, when prior VZV infection is uncertain, a VZV antibody test. Prophylaxis: Isoniazid should be administered in cases of suspected latent TB infection. Antiviral treatment is recommended in HBsAg-positive patients at the start of anti-TNF-alpha treatment. Before anti-TNF-alpha therapy, vaccination with 23-valent pneumococcal vaccine is recommended, and HBV vaccination may be considered in seronegative patients. Annual vaccination against seasonal influenza is recommended. Human papilloma virus vaccination should be administered in accordance with the guidelines of the National Board of Health of Denmark. In patients without a prior VZV infection, VZV vaccination may be considered. Information for patients: Anti-TNF-alpha treatment results in a generally increased risk of infection and latent tuberculosis flare-up. Women are advised to comply with the national guidelines for screening for cervical cancer, and their HPV immunisation status should be clarified. An increased risk of lymphoma with biological therapy in combination with thiopurines should be mentioned. Patients are advised to seek medical advice in case of herpes zoster infection.

Bone mineral density in patients on home parenteral nutrition: a follow-up study.

BACKGROUND AND AIMS: The variations of bone mineral density (BMD) during home parenteral nutrition (HPN) and their relationship with general, life style, primary disease and HPN risk factors were investigated by a follow-up study. DESIGN: Patients who had BMD assessment in a previous cross-sectional survey underwent a 2nd BMD at femoral neck (FN) and lumbar spine (LS). Data about risk factors were collected by a structured questionnaire. BMD Z-score (number of standard deviations from normal values corrected for sex and age) and the annualized percent BMD change were analysed. RESULTS: Sixty-five adult patients were enrolled (follow-up: 18.1+/-5.5 months). The mean BMD Z-score significantly increased at the LS (P = 0.040) and remained unchanged at FN. In multiple regression analysis, the variations of the LS Z-score during HPN negatively correlated with the female sex (P = 0.021) and the age at starting HPN (P = 0.022). The analysis of the annualized percent BMD change confirmed the results obtained by the analysis of the Z-score. No factor was associated with BMD variation at FN. CONCLUSIONS: HPN was not associated with a decrease of BMD in most of the patients; LS BMD Z-score variations were related to general risk factors rather than to HPN factors, showing a negative association with age and female sex.

Assessment of the longitudinal changes in bone mineral density in patients receiving home parenteral nutrition.

BACKGROUND: Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN), but it remains unclear whether or not an accelerated bone loss occurs during HPN therapy. We evaluated the spinal, hip, and forearm bone mass density longitudinally in a cohort of 75 patients receiving HPN. METHODS: A total of 943 regional dual-energy x-ray absorptiometry scans, 335 spinal, 318 hip, and 290 forearm, obtained between 1995 and 2003 in 75 patients receiving HPN, were used for the analysis of the annual changes in BMD. The average (SD) number of scans per patients was 4.4 (2.9), and follow-up time was 4.1 (1.9) years. Diagnoses were Crohn's disease (n = 35) and other conditions (non-Crohn's diseases; n = 40). Data were analyzed using a linear random coefficient model. RESULTS: There was a statistically significant overall decline over time in spinal, hip, and forearm BMD, corresponding roughly to a 1% annual loss (p < .005); however, the loss was not significantly larger than that of age and sex-matched healthy subjects. In Crohn's disease patients, model estimates of spinal and hip BMD on the initiation of HPN therapy were significantly reduced compared with normal, whereas values were not significantly reduced in non-Crohn's disease patients. CONCLUSIONS: With the current protocols for HPN treatment, the annual decline in BMD is moderate and not significantly larger than in age- and sex-matched healthy subjects. A considerable part of the metabolic bone disease in these patients is related to the underlying disease for which the HPN was indicated.

Prevalence of bone disease in patients on home parenteral nutrition.

BACKGROUND & AIMS: The epidemiology of bone disease in home parenteral nutrition (HPN) is unknown. The aim of this paper is to evaluate the prevalence and severity of reduced bone mineral density (BMD) in long-term HPN. DESIGN: Cross-sectional, multicentre study including patients who within the last 12 months had their BMD assessed by dual-energy-X-ray absorptiometry after at least 6 months of HPN. Data on bone pain and fractures, the primary gastrointestinal diseases, nutritional and rehabilitation status and HPN regimen were reviewed. Both the T-score (no. of SD below mean BMD of young subjects) and the Z-score (no. of SD from normal BMD values corrected for sex and age) were analysed. RESULTS: A T -score <-1 at any site of assessment was observed in 84% of the 165 patients enrolled (

Effect of cyclical intravenous clodronate therapy on bone mineral density and markers of bone turnover in patients receiving home parenteral nutrition.

BACKGROUND: Patients receiving home parenteral nutrition (HPN) because of intestinal failure are at high risk of developing osteoporosis. OBJECTIVE: We studied the effect of the bisphosphonate clodronate on bone mineral density (BMD) and markers of bone turnover in HPN patients. DESIGN: A 12-mo, double-blind, randomized, placebo-controlled trial was conducted to study the effect of 1500 mg clodronate, given intravenously every 3 mo for 1 y, in 20 HPN patients with a bone mass T score of the hip or lumbar spine of less than -1. The main outcome measure was the difference in the mean percentage change in the BMD of the lumbar spine measured by dual-energy X-ray absorptiometry. Secondary outcome measures included changes in the BMD of the hip, forearm, and total body and biochemical markers of bone turnover, ie, serum osteocalcin, urinary pyridinoline, and urinary deoxypyridinoline. RESULTS: The mean (+/-SEM) BMD of the lumbar spine increased by 0.8 +/- 2.0% in the clodronate group and decreased by 1.6 +/- 2.0% in the placebo group (P = 0.43). At all secondary skeletal sites (ie, hip, total body, and distal forearm), we observed no changes or small increases in the BMD of the clodronate group and decreases in the BMD of the placebo group. In the clodronate group, biochemical markers of bone resorption decreased significantly (P < 0.05). CONCLUSIONS: Clodronate significantly inhibits bone resorption as assessed by changes in biochemical markers of bone turnover. Although the mean BMD increased in the clodronate group, cyclic clodronate therapy failed to increase spinal BMD significantly at 12 mo.