Hypophosphatemia, FamilialNCT01057186
Hypophosphatemic Rickets in Norway
An observational study of Hypophosphatemia, Familial and Rickets, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to do a follow-up survey of all individuals with hereditary hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The investigators also want to study phenotype-genotype associations, and look for new genes, in all forms of hereditary hypo and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypophosphatemia, Familial, Rickets, Hyperphosphatemia
- What is being tested?
- Alfacalcidol; phosphate. and Sevelamer
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2009to Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The cohorts will be selected from Norwegian patients with hypophosphatemia and hyperphosphatemia.
Who may be able to join
- All patients in the Norwegian population with hereditary hypophosphatemia, with or without rickets
- Patients in the Norwegian population with hereditary hyperphosphatemia
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to do a follow-up survey of all individuals with hereditary hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The investigators also want to study phenotype-genotype associations, and look for new genes, in all forms of hereditary hypo and hyperphosphatemia.
- Conditions
- Hypophosphatemia, Familial, Rickets, Hyperphosphatemia
- Being tested
- Alfacalcidol; phosphate., Sevelamer
- Medical subject headings
- Hypophosphatemia, Familial, Rickets, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfacalcidol; phosphate.Dietary supplement
Individual dosage form and dosage depending on phenotype and underlying cause.
SevelamerDrug
Pills. Individual dosage depending on clinical symptoms/phenotype.
| Study group | Role | What they receive |
|---|---|---|
| hereditary hypophosphatemia | Norwegian patients with hereditary hypophosphatemia. Receives: Dietary Supplement: Alfacalcidol; phosphate. | |
| Hereditary hyperphosphatemia | Norwegian patients with hereditary hyperphosphatemia (hyperphosphatemic familial tumoral calcinosis and hyperphosphatemia hyperostosis syndrome). Receives: Drug: Sevelamer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Change i height z-score from time of diagnosis to last registered consultation.
Measured: Up to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypophosphatemia, FamilialStudies 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
- Cohort
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bjerknes, Professor, MD, PhD, Study director, Haukeland University Hospital, Pediatric department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057186
- Sponsor's protocol ID
- 21922
- Status last verified
- Aug 2016
- First submitted
- 26 Jan 2010
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypophosphatemic Rickets in Norway
- ClinicalTrials.gov ID
- NCT01057186
- Acronym / sponsor ID
- 21922
- Conditions
- Hypophosphatemia, Familial, Rickets, Hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2018 (estimated)
- First posted
- 27 Jan 2010 (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.
The purpose of the study is to do a follow-up survey of all individuals with hereditary hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The investigators also want to study phenotype-genotype associations, and look for new genes, in all forms of hereditary hypo and hyperphosphatemia.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hereditary hypophosphatemia | – | Dietary Supplement: Alfacalcidol; phosphate.Norwegian patients with hereditary hypophosphatemia. |
| Hereditary hyperphosphatemia | – | Drug: SevelamerNorwegian patients with hereditary hyperphosphatemia (hyperphosphatemic familial tumoral calcinosis and hyperphosphatemia hyperostosis syndrome). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The cohorts will be selected from Norwegian patients with hypophosphatemia and hyperphosphatemia.
Key inclusion criteria (2 listed)
- All patients in the Norwegian population with hereditary hypophosphatemia, with or without rickets
- Patients in the Norwegian population with hereditary hyperphosphatemia
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Alfacalcidol; phosphate.Individual dosage form and dosage depending on phenotype and underlying cause. | Dietary supplement | hereditary hypophosphatemia |
| SevelamerPills. Individual dosage depending on clinical symptoms/phenotype. | Drug | Hereditary hyperphosphatemia |
Primary outcome
Growth
Time frame: Up to 18 years
Change i height z-score from time of diagnosis to last registered consultation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
Robert Bjerknes, Professor, MD, PhD study director
Haukeland University Hospital, Pediatric department
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 Hypophosphatemia, Familial and Rickets, run by Haukeland University Hospital at 1 site in Norway.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Aug 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 Norway. 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?
Results are not available in the source record.
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?
Growth (time frame: Up to 18 years). 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 31 Aug 2016.