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| Name | Class |
|---|---|
| University of Sheffield | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported fracture history | ||
| Vertebral fracture assessment | ||
| Radius and tibia geometry and microarchitecture by HR-pQCT |
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Inclusion Criteria:
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
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
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer S Walsh, PhD | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Unit of Bone Metabolism (Sheffield) | Sheffield | South Yorks | S5 7AU | United Kingdom |
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| ID | Term |
|---|---|
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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24 hour urine collections serum samples whole blood samples blood spot on cards
| Serum osteocalcin |
| Blood serotonin and 5HIAA |
| 24h urine 5HIAA | 24 hours |
| Serum type 1 procollagen (N-terminal)(PINP) |
| Bone Alkaline Phosphatase (BAP) |
| Carboxy-terminal collagen crosslinks (CTX) |