Clinical Trial: Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Brief Summary:

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.


Detailed Summary:
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Current Primary Outcome: Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA)

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Self-reported fracture history
  • Vertebral fracture assessment
  • Radius and tibia geometry and microarchitecture by HR-pQCT
  • Serum osteocalcin
  • Blood serotonin and 5HIAA
  • 24h urine 5HIAA [ Time Frame: 24 hours ]
  • Serum type 1 procollagen (N-terminal)(PINP)
  • Bone Alkaline Phosphatase (BAP)
  • Carboxy-terminal collagen crosslinks (CTX)


Original Secondary Outcome: Same as current

Information By: Sheffield Teaching Hospitals NHS Foundation Trust

Dates:
Date Received: August 26, 2011
Date Started: January 2011
Date Completion:
Last Updated: June 14, 2012
Last Verified: June 2012