Effects of Serotonin Excess on Bone in Carcinoid Syndrome

NCT01430871 | Completed

• 1 other identifier: STH15805
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoid Syndrome

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

• Self-reported fracture history

• Vertebral fracture assessment

• Radius and tibia geometry and microarchitecture by HR-pQCT

• Serum osteocalcin

• Blood serotonin and 5HIAA

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Academic Unit of Bone Metabolism (Sheffield)

Sheffield, South Yorks, S5 7AU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Serotonin Syndrome

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Jennifer S Walsh, PhD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: September 8, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

GB (1)