Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Carcinoid Syndrome Clinical Trial

Official title:

Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430871
• Other study ID #: STH15805
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: June 14, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: June 2012
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: National Research Ethics Service (NRES)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Serotonin Syndrome
• Syndrome

Locations

Country	Name	City	State
United Kingdom	Academic Unit of Bone Metabolism (Sheffield)	Sheffield	South Yorks

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA)			No
Secondary	Self-reported fracture history			No
Secondary	Vertebral fracture assessment			No
Secondary	Radius and tibia geometry and microarchitecture by HR-pQCT			No
Secondary	Serum osteocalcin			No
Secondary	Blood serotonin and 5HIAA			No
Secondary	24h urine 5HIAA		24 hours	No
Secondary	Serum type 1 procollagen (N-terminal)(PINP)			No
Secondary	Bone Alkaline Phosphatase (BAP)			No
Secondary	Carboxy-terminal collagen crosslinks (CTX)			No