Hypophosphatemic Rickets in Norway | NCT01057186

Studies
Hypophosphatemic Rickets in Norway

NCT01057186

Sponsor

Haukeland University Hospital

Status

Unknown status

Last Update Posted

Aug 31, 2016Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Hypophosphatemia, Familial
Rickets
Hyperphosphatemia

Interventions

Alfacalcidol; phosphate.
Sevelamer

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Jan 26, 2010

First Posted Date

Jan 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 hyperphosphatemia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hereditary hypophosphatemia		Norwegian patients with hereditary hypophosphatemia.	Dietary Supplement: Alfacalcidol; phosphate.
Hereditary hyperphosphatemia		Norwegian patients with hereditary hyperphosphatemia (hyperphosphatemic familial tumoral calcinosis and hyperphosphatemia hyperostosis syndrome).	Drug: Sevelamer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alfacalcidol; phosphate.	Dietary Supplement	Individual dosage form and dosage depending on phenotype and underlying cause.	hereditary hypophosphatemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Growth	Change i height z-score from time of diagnosis to last registered consultation.	Up to 18 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients in the Norwegian population with hereditary hypophosphatemia, with or without rickets
Patients in the Norwegian population with hereditary hyperphosphatemia

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The cohorts will be selected from Norwegian patients with hypophosphatemia and hyperphosphatemia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Bjerknes, Professor, MD, PhD	Haukeland University Hospital, Pediatric department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital, Childrens departement		Bergen		5021	Norway

Condition Browse Module

MeSH Terms

ID	Term
D007015	Hypophosphatemia, Familial
D012279	Rickets
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D015499	Renal Tubular Transport, Inborn Errors
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008088	alfacalcidol
D010710	Phosphates
D000069603	Sevelamer

Ancestor Terms

ID	Term
D010756	Phosphoric Acids
D017976	Phosphorus Acids
D000148	Acids, Noncarboxylic
D000143	Acids

Browse Leaves

Not provided

Browse Branches

Not provided