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Effects of Serotonin Excess on Bone in Carcinoid Syndrome


N/A
18 Years
N/A
Not Enrolling
Both
Carcinoid Syndrome

Thank you

Trial Information

Effects of Serotonin Excess on Bone in Carcinoid Syndrome


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Jennifer S Walsh, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheffield Teaching Hospitals NHS Foundation Trust

Authority:

UK: National Research Ethics Service (NRES)

Study ID:

STH15805

NCT ID:

NCT01430871

Start Date:

January 2011

Completion Date:

November 2011

Related Keywords:

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

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