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NCT02237625 · ClinicalTrials.gov registry record
Natural History Study of Patients With Hypophosphatasia (HPP)
A clinical trial of Hypophosphatasia, sponsored by Duke University.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT02237625: Recruiting study of Hypophosphatasia, sponsored by Duke University.
NCT02237625 is a study of Hypophosphatasia that is actively recruiting participants, run by Duke University. The registered enrollment target is 200 participants, above the 51-participant average among 6 other Hypophosphatasia trials with a reported enrollment target (292% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02237625, a study of Hypophosphatasia, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypophosphatasia (HPP) is a rare inherited metabolic disorder characterized by defective bone and teeth mineralization caused by mutations of the ALPL gene, which encodes for the tissue-nonspecific alkaline phosphatase (TNSALP) isozyme, resulting in decreased serum and bone alkaline phosphatase levels. To date, over 250 different mutations in the gene encoding TNSALP have been associated with HPP. Clinically, the loss of TNSALP function results in progressive skeletal impact as well as progressive impact on all other major organ systems. It clinically manifests as rickets in infants and children and osteomalacia at all ages. The severe form of the disease has been estimated to have a prevalence of about 1 in every 100,000 live births.
Primary Outcome
Patient clinical data will be collected related to the diagnosis, onset, progression, treatment course and outcome for patients with HPP
Conditions Studied
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2014-09 |
| Est. Completion | 2028-09 |
What NCT02237625 shows while recruiting
NCT02237625 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 51-participant average among 6 other Hypophosphatasia trials with a reported enrollment target (292% higher).
The record links to 1 condition, with Hypophosphatasia appearing as the primary indexed condition, and to 0 interventions.
NCT02237625 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02237625 about?
NCT02237625 is a clinical study titled "Natural History Study of Patients With Hypophosphatasia (HPP)". Hypophosphatasia (HPP) is a rare inherited metabolic disorder characterized by defective bone and teeth mineralization caused by mutations of the ALPL gene, which encodes for the tissue-nonspecific alkaline phosphatase (TNSALP) isozyme, resulting in decreased serum and bone alkaline phosphatase leve...
What is the current status of trial NCT02237625?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2014-09. Estimated completion is 2028-09.
What conditions does trial NCT02237625 study?
This clinical trial studies the following conditions: Hypophosphatasia.
Who is sponsoring clinical trial NCT02237625?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02237625 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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