HypophosphatemiaNCT00688077
FGF-23 Suppressibility by Calcitonin
A study testing Calcitonin in people with Hypophosphatemia, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Introduction: Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypophosphatemia
- What is being tested?
- Calcitonin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2008to Dec 2012
- Phase
- Interventional
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.
Who cannot join
- Serum creatinin >100 mmol/L, or glomerular filtration rate <80 ml/min.
- Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
- Any medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study
Introduction:
Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.
Read more
Aim:
In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.
Study Design:
placebo-controlled, cross-over study
Method:
- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
- On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein.
- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
- Mealtimes: Calcium and Phosphate intake standardized on both occasions
- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23
- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD
Endpoint:
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
- Conditions
- Hypophosphatemia
- Being tested
- Calcitonin, Placebo
- Keywords
- Fibroblast growth factor - 23, Calcitonin
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitoninDrug
Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
PlaceboDrug
NaCl 0,9 % 1ml, single subcutaneous injection, placebo group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Calcitonin |
| 2 | Placebo comparator | NaCl 0,9% 2 ml, single subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
Measured: eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688077
- Sponsor's protocol ID
- LTC-524/030408
- Status last verified
- Jun 2016
- First submitted
- 28 May 2008
- Last updated
- 28 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study
- ClinicalTrials.gov ID
- NCT00688077
- Acronym / sponsor ID
- LTC-524/030408
- Conditions
- Hypophosphatemia
- Keywords
- Fibroblast growth factor - 23, Calcitonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- First posted
- 2 Jun 2008 (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.
Introduction:
Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.
Aim:
In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.
Study Design:
placebo-controlled, cross-over study
Method:
- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
- On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein.
- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
- Mealtimes: Calcium and Phosphate intake standardized on both occasions
- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23
- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD
Endpoint:
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Calcitonin |
| 2 | Placebo comparator | Drug: PlaceboNaCl 0,9% 2 ml, single subcutaneous injection |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.
Key exclusion criteria (3 listed)
- Serum creatinin >100 mmol/L, or glomerular filtration rate <80 ml/min.
- Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
- Any medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcitoninCalcitonin 200 IU/ml, single subcutaneous injection, experimental group | Drug | 1 |
| PlaceboNaCl 0,9 % 1ml, single subcutaneous injection, placebo group | Drug | 2 |
Primary outcome
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
Time frame: eight hours
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 28 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitonin in people with Hypophosphatemia, run by Rijnstate Hospital at 1 site in Netherlands.
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 1 inclusion and 3 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 28 Jun 2016. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU. (time frame: eight hours). 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 28 Jun 2016.