Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)

NCT04181164•Hvidovre University Hospital

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Summary

The study aims to evaluate the bone architecture and bone strength in adults with Hypophosphatasia (HPP).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Genetically verified HPP
•Age: ≥ 18 years
•Persistently low levels of alkaline phosphatase (ALP) ≤ 35 U/L (normal range 35-105 U/L)
•At least one of the following symptoms: a) dental manifestations; b) musculoskeletal pain; c) history of fracture(s)
•Submitted informed consent
•No ALP measurements ≤ 45 U/l and ≥ 50% of all ALP measurements, registered in the electronical clinical journal ≥ 55 U/l
•Normal parathyroid hormone (PTH) and Pyridoxal-5´-phosphate (PLP)
•Vitamin D3 ≥ 25 nmol/L
•Submitted informed consent

Exclusion Criteria

•Pregnancy
•Skin infection or severe skin affection in the measurement area of microindentation
•Known allergy to Lidocain
•Former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral contraception), anti-convulsants)
•Current malignant disorders
•Family history of a genetic metabolic bone disease (HPP, Osteogenesis imperfecta)
•Rickets in childhood
•Former or current Osteoporosis
•Former or current Osteomalacia
•Known diabetes
+7 more criteria

Locations (1)

Hvidovre University Hospital

Hvidovre, Capital Region, Denmark

Key Dates

Start Date

October 1, 2019

Primary Completion Date

September 30, 2021

Completion Date

December 30, 2021

Last Updated

September 1, 2021

Enrollment

ESTIMATED participants

Conditions

Hypophosphatasia (HPP)

Interventions

Microindentation

OTHER

High resolution peripheral quantitative computed tomography (HRpQCT)

OTHER

Biochemical analysis of different bone markers.

BIOLOGICAL

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COMPLETEDPHASE2

Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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