Status:
COMPLETED
Effects of Serotonin Excess on Bone in Carcinoid Syndrome
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Carcinoid Syndrome
Eligibility:
All Genders
18+ years
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 seroton...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01430871
Start Date
January 1 2011
End Date
November 1 2011
Last Update
June 15 2012
Active Locations (1)
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1
Academic Unit of Bone Metabolism (Sheffield)
Sheffield, South Yorks, United Kingdom, S5 7AU