Carcinoid SyndromeNCT01430871
Effects of Serotonin Excess on Bone in Carcinoid Syndrome
An observational study of Carcinoid Syndrome, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoid Syndrome
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Unit of Bone Metabolism (Sheffield)
Sheffield, South Yorks, S5 7AU
About this study
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
- Medical subject headings
- Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
24h urine 5HIAA
Measured: 24 hours
Serum type 1 procollagen (N-terminal)(PINP)
Bone Alkaline Phosphatase (BAP)
Carboxy-terminal collagen crosslinks (CTX)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Jennifer S Walsh, PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430871
- Sponsor's protocol ID
- STH15805
- Status last verified
- Jun 2012
- First submitted
- 26 Aug 2011
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Serotonin Excess on Bone in Carcinoid Syndrome
- ClinicalTrials.gov ID
- NCT01430871
- Acronym / sponsor ID
- STH15805
- Conditions
- Carcinoid Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA)
9 secondary outcomes
Self-reported fracture history
Vertebral fracture assessment
Radius and tibia geometry and microarchitecture by HR-pQCT
Serum osteocalcin
Blood serotonin and 5HIAA
24h urine 5HIAA
Time frame: 24 hours
Serum type 1 procollagen (N-terminal)(PINP)
Bone Alkaline Phosphatase (BAP)
Carboxy-terminal collagen crosslinks (CTX)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer S Walsh, PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoid Syndrome, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine and total hip Bone Mineral Density BMD) measured by Dual-emission X-ray absorptiometry (DXA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2012.