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Hypophosphatemic Rickets in Norway

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057186
First Posted: January 27, 2010
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose
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.

Condition Intervention
Hypophosphatemia, Familial Rickets Hyperphosphatemia Dietary Supplement: Alfacalcidol; phosphate. Drug: Sevelamer

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Hypophosphatemic Rickets in Norway

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Growth [ Time Frame: Up to 18 years ]
    Change i height z-score from time of diagnosis to last registered consultation.


Biospecimen Retention:   Samples With DNA
EDTA plasma, serum, urine

Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hereditary hypophosphatemia
Norwegian patients with hereditary hypophosphatemia.
Dietary Supplement: Alfacalcidol; phosphate.
Individual dosage form and dosage depending on phenotype and underlying cause.
Hereditary hyperphosphatemia
Norwegian patients with hereditary hyperphosphatemia (hyperphosphatemic familial tumoral calcinosis and hyperphosphatemia hyperostosis syndrome).
Drug: Sevelamer
Pills. Individual dosage depending on clinical symptoms/phenotype.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The cohorts will be selected from Norwegian patients with hypophosphatemia and hyperphosphatemia.
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057186


Locations
Norway
Haukeland University Hospital, Childrens departement
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Director: Robert Bjerknes, Professor, MD, PhD Haukeland University Hospital, Pediatric department
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01057186     History of Changes
Other Study ID Numbers: 21922
First Submitted: January 26, 2010
First Posted: January 27, 2010
Last Update Posted: August 31, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Hyperphosphatemia
Rickets
Hypophosphatemia
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Hypophosphatemia, Familial
Phosphorus Metabolism Disorders
Metabolic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Sevelamer
Alfacalcidol
Hydroxycholecalciferols
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents