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Natural History Study of Hypophosphatasia (HPP)

This is an observational study looking at the natural history of Hypophosphatasia (HPP), a rare genetic condition affecting bone and teeth development. The study aims to gather detailed information about how HPP affects people over time, including bone problems, eye issues, and other health concerns. Researchers hope to create a better understanding of the disease to improve care for patients. You may be able to join if you have a confirmed diagnosis of HPP, which means your serum alkaline phosphatase (ALP) levels are low for your age or your plasma PLP levels are high. The study plans to enroll 200 participants. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information about your health over time without providing any specific treatments. The study plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, "Medical History of HPP Patients," is measured at 100 years, suggesting a very long-term follow-up.

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NCT02237625

Natural History Study of Patients With Hypophosphatasia (HPP)

Recruiting
Not specifiedAll AgesObservational
Duke University
~200 participants
Updated 2026-03-05 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Medical History of HPP Patients
Measured over 100 years

Conditions

Hypophosphatasia

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HypophosphatasiaAlkaline PhosphataseALPL GeneMyelin Proteolipid Protein

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Priya Kishnani, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Janet G Blount, BA
[email protected]
919-681-7962
Email the study team

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Eligibility criteria

Inclusion

Patients or their legal representative must provide written informed consent or, if applicable, qualify for waiver of consent.
Patients must have a pre-established clinical diagnosis of HPP, as indicated by one or more of the following:
Serum alkaline phosphatase (ALP) below the age-adjusted normal range
Plasma PLP at least twice the upper limit of normal (no vitamin B6 administered for at least 1 week prior to determination)
Evidence of osteopenia or osteomalacia on skeletal radiographs
Genetic analysis fof the ALPL gene
Must be current patient in the Duke University System.

Exclusion

Any patient without confirmation of clinical diagnosis of HPP.

What this trial measures

  • Medical History of HPP Patients100 years

    Patient clinical data will be collected related to the diagnosis, onset, progression, treatment course and outcome for patients with HPP