NCT01430871|Completed
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Sponsor study identifier
observational
52
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Serotonin has recently been identified as a major regulator of bone formation. Gut-derived serotonin inhibits bone formation, and early animal studies have shown that inhibition of gut-derived serotonin has anabolic effects on bone in ovariectomised rodents. This pathway has potential to be developed as a new anabolic treatment for osteoporosis in humans. Carcinoid neuro-endocrine tumours produce very high levels of serotonin, and so it might be expected that patients with carcinoid disease would have reduced bone formation, low bone mass and fractures. However, this has not been apparent in clinical practice. There may be a discrepancy between rodent models and human disease. This study aims to identify whether patients with carcinoid disease have reduced bone mass, reduced bone formation or high fracture rates. The investigators will conduct a cross-sectional observational case-control study of patients with carcinoid disease in the Sheffield neuro-endocrine tumour clinic and gender-, age- and body mass index (BMI)-matched controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 26, 2011
Actual (reported)September 8, 2011
Actual (reported)November 2011
Actual (reported)November 2011
Actual (reported)Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA)
Self-reported fracture history
Vertebral fracture assessment
Radius and tibia geometry and microarchitecture by HR-pQCT
Serum osteocalcin
Blood serotonin and 5HIAA
Patients: Men and women age 18 years or older with carcinoid syndrome attending the Sheffield neuro-endocrine tumour clinic
Control group: Healthy men and women individually matched to the patients by gender, age, height and BMI
Men and women age 18 years or older with carcinoid syndrome attending the Sheffield neuro-endocrine tumour clinic Healthy men and women individually matched to the patients by gender, age, height and BMI
Academic Unit of Bone Metabolism (Sheffield)
Sheffield, South Yorks, S5 7AU, United Kingdom
24 hour urine collections serum samples whole blood samples blood spot on cards
Jennifer S Walsh, PhD
Sheffield Teaching Hospitals NHS Foundation Trust
52 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2011
First Posted
September 8, 2011
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Contact the study team to confirm eligibility.
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
June 15, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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