Trial record 4 of 58 for:    "Carcinoid syndrome"

Effects of Serotonin Excess on Bone in Carcinoid Syndrome

This study has been completed.
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01430871
First received: August 26, 2011
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition
Carcinoid Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported fracture history [ Designated as safety issue: No ]
  • Vertebral fracture assessment [ Designated as safety issue: No ]
  • Radius and tibia geometry and microarchitecture by HR-pQCT [ Designated as safety issue: No ]
  • Serum osteocalcin [ Designated as safety issue: No ]
  • Blood serotonin and 5HIAA [ Designated as safety issue: No ]
  • 24h urine 5HIAA [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Serum type 1 procollagen (N-terminal)(PINP) [ Designated as safety issue: No ]
  • Bone Alkaline Phosphatase (BAP) [ Designated as safety issue: No ]
  • Carboxy-terminal collagen crosslinks (CTX) [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

24 hour urine collections serum samples whole blood samples blood spot on cards


Enrollment: 52
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Carcinoid syndrome
Patients: Men and women age 18 years or older with carcinoid syndrome attending the Sheffield neuro-endocrine tumour clinic
Healthy Volunteers
Control group: Healthy men and women individually matched to the patients by gender, age, height and BMI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Willing to participate
  • Able to give informed consent
  • Patient with carcinoid syndrome-active disease (untreated or receiving medical treatment)
  • or
  • Healthy volunteer who adequately matches a patient with carcinoid syndrome gender, age (±5 years), height (±5cm) and BMI(±3 kg/m2)

Exclusion Criteria:

  • Curative surgery for carcinoid disease
  • Body weight over 159 kg (weight limit for DXA measurement of BMD)
  • Previous orthopaedic surgery or fractures which preclude imaging at all sites
  • History of any long term immobilization (duration greater than three months)
  • Fracture less than one year prior to recruitment
  • Current pregnancy or trying to conceive
  • Delivery of last child less than one year prior to recruitment
  • Breast feeding less than one year prior to recruitment
  • History of, or current conditions known to affect bone metabolism

    • Diagnosed skeletal disease or inflammatory arthritis
    • Chronic renal disease
    • Malabsorption syndromes
    • Other diagnosed endocrine disorders
    • Hypocalcemia or hypercalcemia
    • Diagnosed restrictive eating disorder
    • Diabetes mellitus
  • Conditions or surgery which prevent the acquisition or analysis of DXA, VFA or HR-pQCT
  • Use of medications or treatment known to affect bone metabolism
  • Alcohol intake greater than 21 units per week
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430871

Locations
United Kingdom
Academic Unit of Bone Metabolism (Sheffield)
Sheffield, South Yorks, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
Principal Investigator: Jennifer S Walsh, PhD Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01430871     History of Changes
Other Study ID Numbers: STH15805
Study First Received: August 26, 2011
Last Updated: June 14, 2012
Health Authority: UK: National Research Ethics Service (NRES)

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014