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NCT Number: NCT01430871

Effects of Serotonin Excess on Bone in Carcinoid Syndrome

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.

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Key information

Conditions

Carcinoid Syndrome Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Serotonin Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Unit of Bone Metabolism (Sheffield)

Sheffield, South Yorks, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA)

Secondary outcomes

  1. Self-reported fracture history

  2. Vertebral fracture assessment

  3. Radius and tibia geometry and microarchitecture by HR-pQCT

  4. Serum osteocalcin

  5. Blood serotonin and 5HIAA

  6. 24h urine 5HIAA

    Time frame: 24 hours

  7. Serum type 1 procollagen (N-terminal)(PINP)

  8. Bone Alkaline Phosphatase (BAP)

  9. Carboxy-terminal collagen crosslinks (CTX)

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2011
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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