Clinical Trial for Cortendo

Posted on March 13, 2015 by MaryO

Cortendo Clinical Trial

 

About the Study

OBJECTIVE:

The purpose of this study is to test the effects of different doses of COR-003 on people with endogenous Cushing’s syndrome, primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, liver function, etc. This study is also being conducted to find out if COR-003 is safe to use. This study is open-label, which means both the health providers and the participants in the study are aware of the drug or treatment being given.

STUDY DESIGN:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken by mouth in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for 6 months.
  • Finally, participants will continue in the study for an additional 6 months at doses to be determined by the study doctor.
  • Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.
  • Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year.

See if you may be eligible for this clinical study. By providing your contact information, you will receive more information about the study and your eligibility.

About Cortendo

Cortendo is the sponsor of this study. This means Cortendo planned and organized this study. Cortendo will also collect and analyze the data from the study.

Cortendo is a global pharmaceutical company primarily focused on researching and providing treatments for rare diseases in endocrinology, such as Cushing’s syndrome. The company was founded in Sweden and its worldwide headquarters is located just outside of Philadelphia.

Fill out this form for more information: https://www.cushingssyndromestudy.com/registration.aspx

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Does a normal urine free cortisol result rule out Cushing’s syndrome?

Posted on March 7, 2015 by MaryO

ENDO_2015

 

March 07, 2015

SAT 379-412-Cushing’s Syndrome

Does a normal urine free cortisol result rule out Cushing’s syndrome?

ST Sharma, LK Nieman

Summary: Researchers conducted this study to assess the diagnostic accuarcy of urine free cortisol (UFC) and 24-hour urine 17-hydroxycorticosteroids (170HCS) in patients with Cushing’s syndrome, concluding that in patients with mild CS, UFC can be falsely normal or only minimally elevated. Further, they found that to help in making a diagnosis and prevent treatment delays, clinicians may consider incorporating multiple collections and use of complimentary screening tests including 24-hour urine 17OHCS and late night salivary cortisol (LNSC) testing.

Methods:

  • For this retrospective study, researchers included all CS patients evaluated at the National Institutes of Health (NIH) from 2009 to 2014.
  • The screening tests used for CS included UFC, 17OHCS, midnight serum cortisol and low dose (1 mg overnight or 2-day 2 mg/day) dexamethasone suppression test (DST).
  • They defined abnormal as values above reference range for UFC, 17OHCS and LNSC, a midnight serum cortisol ≥7.5 mcg/dL, and post-dexamethasone cortisol values ≥1.8 mcg/dL.
  • Hourly 24-hour sampling for cortisol was performed in a few cases with a mild clinical phenotype and equivocal test results.
  • Researchers measured UFC using liquid chromatography/tandem mass spectrometry (LC-MS/MS), and 17OHCS was measured using colorimetric methodology with Porter-Silber reaction (reported as mg/g of creatinine).
  • For this study, they used the mean of the first two UFC and 17OHCS values (appropriate collection by urine volume and creatinine) obtained within 30 days of initial NIH presentation.

Results:

  • In all, 72 patients were diagnosed with CS (aged 18-77 years, 51 females), 51 of whom had CD, 10 had ectopic CS, and 2 had an adrenal source of Cushing’s based on pathology.
  • Biochemical tests such as inferior petrosal sinus sampling (IPSS) suggested ectopic CS, but no tumor was found (occult) in 6 patients.
  • In 2 patients with failed transsphenoidal surgery, IPSS was indicative of a pituitary source, and one patient did not complete evaluation for ACTH-dependent CS.
  • UFC results were available in all patients, 17OHCS in 70, LNSC in 21, midnight serum cortisol in 68, and DST results in 37 patients.
  • UFC was falsely normal in 6 patients and only minimally elevated (<2 x ULN) in 13 patients (normal renal function, no history of cyclicity, all had CD); of these 19 patients, 24-hour 17OHCS was abnormal in all, LNSC was abnormal in 12, midnight serum cortisol was abnormal in 18, and DST was abnormal in 12 patients.
  • Hourly 24-hour sampling for cortisol performed in 3 of these patients revealed abnormal nadir (>7.5 mcg/dL) and mean daily serum cortisol (>9 mcg/dL) levels.

From http://www.mdlinx.com/endocrinology/conference-abstract.cfm/ZZ5BA369FDE9DE4CED82CB6A7CD5BFD1BE/42581/?utm_source=confcoveragenl&utm_medium=newsletter&utm_content=abstract-list&utm_campaign=abstract-ENDO2015&nonus=0

Filed under: Clinical trials, Cushing's, Meetings and Conferences, pituitary, Treatments | Tagged: , , , , , , , , , , , | Leave a comment »

OR17-Novel Aspects of Adrenal Tumors and the HPA Axis

Posted on March 6, 2015 by MaryO

ENDO_2015

 

March 06, 2015

OR17-Novel Aspects of Adrenal Tumors and the HPA Axis

Epigenetic modulation of DNA Is associated with fatigue, depression and anxiety in patients with Cushing’s syndrome in remission: A genome-wide methylation study

CAM Glad, JC Andersson-Assarsson, P Berglund, R Bergthorsdottir, O Ragnarsson, G Johannsson

Summary: Researchers conducted this study to determine whether patients with Cushing’s syndrome (CS) that is in remission have specific epigenetic alterations that are associated with persistent cognitive impairments, anxiety, fatigue, and depression. Patients with CS in remission were shows to have specific DNA methylation that differed from that of healthy controls and was strongly correlated with clinical traits of anxiety, depression and fatigue, they concluded, adding that their results may suggest that an interaction between the glucocorticoid and the retinoic acid receptor is implicated in the long-term outcome of patients with CS in remission. The persistent cognitive impairment observed in patients with CS in remission, therefore, may be due to epigenetic modulation of DNA, they concluded.

Methods:

  • For this cross-sectional, case-controlled, single center study, researchers included 48 women with CS in remission (mean age±SD: 52.9±14 years) and 16 controls (mean age±SD: 53.6±16 years) matched for age, gender and educational level.
  • The mean age at diagnosis of CS was 37±14 years and the median (interquartile range) duration of remission was 13 (5-19) years.
  • In all, 37 patients had Cushing’s disease (CD) and 11 had a cortisol producing adrenal adenoma.
  • Researchers used the fatigue impact scale (FIS) to evaluate fatigue, and the comprehensive psychopathological rating scale to evaluate depression and anxiety; they assessed cognitive function by standardized neuropsychological tests.
  • DNA was isolated from whole blood, and DNA methylation was analyzed on the Illumina Infinium HumanMethylation450K BeadChip, which simultaneously interrogates >465,000 methylation sites per sample.
  • Researchers performed data quality control and analysis using the ChAMP methylation analysis package in R, and used Spearmen’s rho to perform correlation analyses.

Results:

  • Researchers found that patients had higher median score for FIS, depression and anxiety.
  • Methylation analysis identified 3,903 probes (in 340 genes) in regions that were differently methylated between CS patients and controls, and they found that 28% of these were significantly correlated to at least one of the clinical traits.
  • Fatigue, depression and anxiety were the most commonly correlated traits, and two of the most highly correlated genes were RXRB and COL11A2.
  • Gene ontology analysis revealed that these belong to the same GO-terms and are involved in retinoic acid receptor activity.
  • Finally, researchers found that both genes were specifically hypomethylated in cases as compared to controls.

 

This project has received financial support from the Swedish federal government under the LUA/ALF agreement, The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland, The Swedish Society of Medicine and The Swedish Society of Endocrinology.

From http://www.mdlinx.com/endocrinology/conference-abstract.cfm/ZZ5BA369FDE9DE4CED82CB6A7CD5BFD1BE/42321/?utm_source=confcoveragenl&utm_medium=newsletter&utm_content=abstract-list&utm_campaign=abstract-ENDO2015&nonus=0

Filed under: adrenal, Clinical trials, Cushing's, Meetings and Conferences, pituitary | Tagged: , , , , , , , , , , , , | Leave a comment »

Day 2 Coverage of ENDO 2015

Posted on March 6, 2015 by MaryO

ENDO_2015

 

OR22-Osteoporosis–Winner: Outstanding Abstract Award

Effects of teriparatide on bone microarchitecture in postmenopausal women with osteoporosis
S Orlov, R Ridout, L Tile, M Kapral, S Cardew, MR Werb, SD Sandler, J Chang, H Hu, E Szabo, C Derzko, A Cheung

FRI 224-247-Metabolic and Genetic Bone Disorders

The effect of vitamin D supplementation on falls and physical performance in elderly women. A randomized clinical trial
S Yousefian, JC Gallagher, SH Tella

The etiology and risk factors analysis in hypercalcemic crisis
H Liao, DL Lorber, E Cohen

LBF 001-014-Late-breaking Thyroid/HPT Axis II

Diagnostic lobectomy for thyroid nodules >4 cm with benign cytology after fine-needle aspiration is associated with improved outcomes at an acceptable cost compared to observation: …
L Lee, E Theodosopoulos, EJ Mitmaker, JA Lee, J Chabot, JH Kuo

LBF 015-023-Late-breaking Reproductive Endocrinology II

Effect of testosterone treatment on cardiac biomarkers in a randomized controlled trial of men with type 2 diabetes
EJ Gianatti, R Hoermann, Q Lam, P Dupuis, JD Zajac, M Grossmann

OR17-Novel Aspects of Adrenal Tumors and the HPA Axis

Epigenetic modulation of DNA Is associated with fatigue, depression and anxiety in patients with Cushing’s syndrome in remission: A genome-wide methylation study
CAM Glad, JC Andersson-Assarsson, P Berglund, R Bergthorsdottir, O Ragnarsson, G Johannsson

Pharmacogenetic analysis of glucocorticoid gene polymorphisms and prediction of daily dexamethasone doses in adults with congenital adrenal hyperplasia
JS Frassei, LG Gomes, RP Moreira, G Madureira, BB Mendonca, TA Bachega

OR20-Pituitary Tumors-New Clinical Considerations

Reduced mortality in patients with GH replacement therapy – a Swedish study based on more than 4,000 patient-years
DS Olsson, AG Nilsson, P Trimpou, B-A Bengtsson, E Andersson, G Johannsson

OR22-Osteoporosis

Denosumab restores cortical bone loss at the 1/3 radius associated with aging and reduces wrist fracture risk: Analyses from the Freedom extension cross-over group
JP Bilezikian, CL Benhamou, CJF Lin, JP Brown, NS Daizadeh, PR Ebeling, A Fahrleitner-Pammer, E Franek, N Gilchrist, PD Miller, JA Simon1, I Valter, AF Zerbini, C Libanati

OR22-Osteoporosis–Winner Clinical Fellows Abstract Award Travel Grants in Womens Health

Estrone may be more important than testosterone and estradiol for bone health and prevention of fractures in post-menopausal women
G Toraldo, TG Travison, X Zhang, KE Broe, S Bhasin, DP Kiel, AD Coviello

Filed under: adrenal, Clinical trials, growth hormone, Meetings and Conferences, pituitary, Rare Diseases, Treatments | Tagged: , , , , , , , , , , , , | Leave a comment »

Rare Disease Day ® 2015 – Theme of the Year: Care

Posted on February 27, 2015 by MaryO

rare-disease-day-2015

Theme: Living with a Rare Disease – Slogan: Day-by-day, hand-in-hand

2015 marks eight consecutive, successful years of Rare Disease Day. Continuing the momentum, Rare Disease Day 2015 puts the focus on the daily lives of patients, families and caregivers who are Living with a Rare Disease.

Over 6000 different rare diseases have been identified to date, directly affecting the daily life of more than 30 million people in Europe alone. The complex nature of rare diseases, coupled with limited access to treatment and services, means that family members are often the primary source of solidarity, support and care for their loved ones. The Rare Disease Day 2015 theme Living with a Rare Disease pays tribute to the millions and millions of parents, siblings, grandparents, spouses, aunts, uncles, cousins, and friends whose daily lives are impacted and who are living day-by-day, hand-in-hand with rare disease patients.

Typically chronic and debilitating, rare diseases have enormous repercussions for the whole family. Living with a rare disease becomes a daily learning experience for patients and families. Though they have different names and different symptoms, rare diseases impact the daily lives of patients and families in similar ways.

How to find a diagnosis?

How to access treatments?

How to find appropriate expertise?

How to work with a team of caregivers, such as doctors or physical therapists, and other healthcare professionals and coordinate care between them?

How to operate special equipment?

How to administer treatments?

How to identify and access social services?

How to manage the economic burden of living with a rare disease?

How to ensure the well-being of the entire family and balance priorities?

Patient organisations become a crucial source of information, experience and resources. Day-by-day, hand-in-hand, together we present a united voice to advocate for the treatments, care, resources and services we all need. Patients, families and organisations are pivotal to the momentum of creating solutions for the daily challenges of living with a rare disease in solidarity with all stakeholders – caregivers, healthcare professionals, specialised social services, researchers, pharmaceutical companies, policy makers, and regulatory bodies.

Internationally, it is essential to send a strong message of solidarity to the countless rare disease patients and families throughout the entire world. Together, we can transform the individual experience of patients and relatives around the world into collective actions, support, advocacy and community building.

via Rare Disease Day ® 2015 – Theme of the Year: Care.

Filed under: adrenal, Clinical trials, Cushing, Cushing's, Inspiration, Meetings and Conferences, pituitary, Rare Diseases | Leave a comment »

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