Effects of Serotonin Excess on Bone in Carcinoid Syndrome
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Purpose
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.
| Condition |
|---|
|
Carcinoid Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Effects of Serotonin Excess on Bone in Carcinoid Syndrome |
- Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA) [ Designated as safety issue: No ]
- Self-reported fracture history [ Designated as safety issue: No ]
- Vertebral fracture assessment [ Designated as safety issue: No ]
- Radius and tibia geometry and microarchitecture by HR-pQCT [ Designated as safety issue: No ]
- Serum osteocalcin [ Designated as safety issue: No ]
- Blood serotonin and 5HIAA [ Designated as safety issue: No ]
- 24h urine 5HIAA [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Serum type 1 procollagen (N-terminal)(PINP) [ Designated as safety issue: No ]
- Bone Alkaline Phosphatase (BAP) [ Designated as safety issue: No ]
- Carboxy-terminal collagen crosslinks (CTX) [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
24 hour urine collections serum samples whole blood samples blood spot on cards
| Enrollment: | 52 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
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
Contacts and Locations| United Kingdom | |
| Academic Unit of Bone Metabolism (Sheffield) | |
| Sheffield, South Yorks, United Kingdom, S5 7AU | |
| Principal Investigator: | Jennifer S Walsh, PhD | Sheffield Teaching Hospitals NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Sheffield Teaching Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01430871 History of Changes |
| Other Study ID Numbers: | STH15805 |
| Study First Received: | August 26, 2011 |
| Last Updated: | June 14, 2012 |
| Health Authority: | UK: National Research Ethics Service (NRES) |
Additional relevant MeSH terms:
|
Carcinoid Tumor Malignant Carcinoid Syndrome Serotonin Syndrome Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Drug Toxicity Poisoning Substance-Related Disorders Serotonin Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013