Patients with Growth-Related Disorders and Caregivers Prefer the Somapacitan Device to the Somatrogon Device: Results from a Randomized Crossover Study Assessing Device Preference and Ease of Use Following Simulated Injections.

Purpose: Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya, Novo Nordisk A/S) and somatrogon (Ngenla, Pfizer).

Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial.

Study Design And Objective: Randomised, double-blind, crossover trial to confirm bioequivalence of somapacitan, a long-acting growth hormone (GH), in 5 mg/1.5 mL and 10 mg/1.5 mL strengths in equimolar doses.

Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.

Purpose: The long-term effects of long-acting growth hormone (LAGH) analogues on glucose metabolism in adult growth hormone deficiency (AGHD) are not known. We investigated the impact of LAGH somapacitan, administered once-weekly, on glucose metabolism in patients with AGHD.

Methods: In post hoc-defined analyses, we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan).

Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.

Context: Growth hormone (GH) replacement requires daily GH injections, which is burdensome for some adult patients with GH deficiency (AGHD).

Objective: To demonstrate efficacy and safety of somapacitan, a once-weekly reversible albumin-binding GH derivative, versus placebo in AGHD.

Design: Randomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).

Cancer Risk and Prognosis after a Hospital Contact for an Elevated Erythrocyte Sedimentation Rate.

Background: An elevated erythrocyte sedimentation rate (ESR) may be a marker of occult cancer.

Methods: We linked Danish medical databases to examine cancer incidence in patients with a first-time hospital contact for elevated ESR during 1980 to 2013. We calculated standardized incidence ratios (SIR) of cancer compared with the general population, and comorbidity-adjusted HRs (aHR) versus matched population comparisons without elevated ESR.

Low to Moderate Average Alcohol Consumption and Binge Drinking in Early Pregnancy: Effects on Choice Reaction Time and Information Processing Time in Five-Year-Old Children.

Background: Deficits in information processing may be a core deficit after fetal alcohol exposure. This study was designed to investigate the possible effects of weekly low to moderate maternal alcohol consumption and binge drinking episodes in early pregnancy on choice reaction time (CRT) and information processing time (IPT) in young children.

Method: Participants were sampled based on maternal alcohol consumption during pregnancy.

Hospital use among patients with lung cancer complicated by bone metastases and skeletal- related events: a population-based cohort study in Denmark.

Objective: Skeletal-related events (SREs) among patients with bone metastases from lung cancer may be associated with considerable use of health care resources. We analyzed in- and outpatient hospital contacts in relation to SREs among all Danish lung cancer patients with bone metastases.

Methods: For this cohort study, we used the Danish Cancer Registry and the Danish National Registry of Patients to identify all persons diagnosed with first-time lung cancer and bone metastases from 2003 through 2009 in Denmark.

Evaluation of an ICD-10 algorithm to detect osteonecrosis of the jaw among cancer patients in the Danish National Registry of Patients.

Purpose: This study aimed to validate a predefined algorithm for osteonecrosis of the jaw (ONJ) among cancer patients in the Danish National Registry of Patients and to assess the nature of clinical information recorded in medical charts of ONJ patients.

Methods: We identified potential ONJ cases recorded in 2005-2010 among cancer patients at the hospital Departments of Oral and Maxillofacial Surgery (DOMS) in three Danish regions, using a set of codes from the International Classification of Diseases, 10th revision (ICD-10). We abstracted DOMS charts of the potential cases, had the ONJ status adjudicated by an expert ONJ adjudication committee (ONJAC), and computed positive predictive values.

Survival in patients with breast cancer with bone metastasis: a Danish population-based cohort study on the prognostic impact of initial stage of disease at breast cancer diagnosis and length of the bone metastasis-free interval.

Objectives: Since population-based data on prognostic factors affecting survival in patients with breast cancer with bone metastasis (BM) are currently limited, we conducted this nationwide retrospective cohort study to examine the prognostic role of disease stage at breast cancer diagnosis and length of BM-free interval (BMFI).

Setting: Denmark.

Participants: 2427 women with a breast cancer diagnosis between 1997 and 2011 in the Danish Cancer Registry and a concurrent or subsequent BM diagnosis in the Danish National Registry of Patients.

The impact of chronic obstructive pulmonary disease on intensive care unit admission and 30-day mortality in patients undergoing colorectal cancer surgery: a Danish population-based cohort study.

Background And Purpose: Chronic obstructive pulmonary disease (COPD) may increase the risk of postoperative complications and thus mortality after colorectal cancer (CRC) surgery, but the evidence is sparse.

Methods: We conducted this nationwide population-based cohort study in Denmark, including all patients undergoing CRC surgery in the period 2005-2011, identified through medical databases. We categorised the patients according to the history of COPD.

Risk and prognosis of cancer in patients with nephrotic syndrome.

Background: Nephrotic syndrome may be a marker of occult cancer, but population-based studies of this association are lacking. Therefore, we examined the risk and prognosis of cancer in patients with nephrotic syndrome.

Methods: We conducted this population-based cohort study in Denmark, including all individuals diagnosed with nephrotic syndrome between 1980 and 2010 without a preceding cancer history.

Risk of colorectal cancer in patients with acute myocardial infarction and stroke: a nationwide cohort study.

Background: An association between colorectal cancer and acute myocardial infarction (AMI) and stroke has been suggested, but evidence is conflicting.

Method: We conducted a population-based cohort study (1978-2010) of the association between AMI/stroke and colorectal cancer by linking nationwide Danish registries. We calculated standardized incidence ratios (SIR) of colorectal cancer after AMI/stroke as the ratios of observed to expected incidence.

Validity of an algorithm to identify osteonecrosis of the jaw in women with postmenopausal osteoporosis in the Danish National Registry of Patients.

Background: Osteonecrosis of the jaw (ONJ) is an adverse effect of drugs that suppress bone turnover - for example, drugs used for the treatment of postmenopausal osteoporosis. The Danish National Registry of Patients (DNRP) is potentially valuable for monitoring ONJ and its prognosis; however, no specific code for ONJ exists in the International Classification of Diseases 10th revision (ICD-10), which is currently used in Denmark. Our aim was to estimate the positive predictive value (PPV) of an algorithm to capture ONJ cases in the DNRP among women with postmenopausal osteoporosis.

Hospital visits among women with skeletal-related events secondary to breast cancer and bone metastases: a nationwide population-based cohort study in Denmark.

Objective: Skeletal-related events (SREs) among women with breast cancer may be associated with considerable use of health-care resources. We characterized inpatient and outpatient hospital visits in a national population-based cohort of Danish women with SREs secondary to breast cancer and bone metastases.

Methods: We identified first-time breast cancer patients with bone metastases from 2003 through 2009 who had a subsequent SRE (defined as pathologic fracture, spinal cord compression, radiation therapy, or surgery to bone).

Cancer risk among patients with congenital heart defects: a nationwide follow-up study.

Objective: We aimed to assess cancer risk in congenital heart defect patients, with and without Down's syndrome, compared with the general population.

Methods: We identified all patients born and diagnosed with congenital heart defects from 1977 to 2008 using the Danish National Registry of Patients, covering all Danish hospitals. We compared cancer incidence in the congenital heart defect cohort with that expected in the general population (∼5.

Endocarditis and risk of cancer: a Danish nationwide cohort study.

Background: Endocarditis may be a marker for bacteremia-associated occult cancer. Intensive antibiotic treatment in endocarditis is suggested to reduce long-term cancer risk. We examined these hypotheses in a nationwide cohort study.

Lymph node enlargement and risk of haematological and solid cancer.

Enlarged lymph nodes may be a marker of occult cancer, but accurate data on cancer risk are limited. We used population-based Danish medical registries to assess cancer risk in a cohort of patients with a first-time inpatient or outpatient hospital contact for enlarged lymph nodes during 1994-2008. Observed cancer incidences were compared with that expected in the general population.

The effects of low to moderate alcohol consumption and binge drinking in early pregnancy on selective and sustained attention in 5-year-old children.

Objective: The aim was to examine the effects of low to moderate maternal alcohol consumption and binge drinking in early pregnancy on children's attention at 5 years of age.

Design: Prospective follow-up study.

Setting: Neuropsychological testing in four Danish cities 2003-2008.

Thirty-day mortality after elective and emergency total colectomy in Danish patients with inflammatory bowel disease: a population-based nationwide cohort study.

Objectives: The purpose of this investigation was to assess 30-day mortality among Danish inflammatory bowel diseases (IBD) patients and to examine the prognostic impact of hospital total colectomy volume, age, gender and comorbidity.

Design: Cohort study.

Setting: The authors compared 30-day survival over the period 1996-2010 among 2889 IBD patients with total colectomy identified in the Danish National Registry of Patients.

Risk of cancer in patients with inflammatory bowel disease and venous thromboembolism: a nationwide cohort study.

Background: Venous thromboembolism (VTE) may be a harbinger of cancer. Inflammatory bowel disease (IBD) is known to increase the risk of VTE, but it is unclear whether VTE in IBD patients is also a marker for occult cancer. We assessed the risk of cancer after VTE in IBD patients.

Chronic obstructive pulmonary disease and cancer risk: a Danish nationwide cohort study.

Introduction: Little is known about the risk of cancer in patients with chronic obstructive pulmonary disease (COPD), including which cancer sites are most affected. We examined the short- and long-term risk of lung and extrapulmonary cancer in a nationwide cohort of COPD patients.

Methods: We linked the Danish National Registry of Patients and the nationwide cancer registry, and examined the incidence of various cancers in 236,494 individuals with a first incident hospital contact with COPD during 1980-2008.

Atopic dermatitis and risk of skin cancer: a Danish nationwide cohort study (1977-2006).

Background: Recent data suggest a reduced risk of malignant melanoma (MM) among atopic dermatitis (AD) patients, but an increased risk of other skin cancers (including basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]).

Objective: We examined the association between AD and skin cancers in a large cohort study in Denmark from 1977 through 2006.

Methods: Our cohort consisted of 31 330 AD patients recorded in the Danish National Patient Registry, including AD patients admitted to hospitals and specialized outpatient clinics.

Superficial and deep venous thrombosis, pulmonary embolism and subsequent risk of cancer.

Background: In contrast to deep venous thrombosis and pulmonary embolism, superficial venous thrombosis has not been considered to be a marker of occult cancer. However, actual data regarding the association are very limited.

Methods: We identified all patients in Denmark from 1994 to 2009 with a diagnosis of superficial venous thrombosis, deep venous thrombosis in the legs or pulmonary embolism using population-based health registries.