Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)
NCT ID: NCT04181164
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2019-10-01
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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HPP-Group
Adults with hypophosphatasia.
Microindentation
Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.
High resolution peripheral quantitative computed tomography (HRpQCT)
HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.
Biochemical analysis of different bone markers.
Measurement of different bone markers by biochemical analysis of blood samples.
Control-Group
Healthy control subjects.
Microindentation
Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.
High resolution peripheral quantitative computed tomography (HRpQCT)
HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.
Biochemical analysis of different bone markers.
Measurement of different bone markers by biochemical analysis of blood samples.
Interventions
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Microindentation
Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.
High resolution peripheral quantitative computed tomography (HRpQCT)
HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.
Biochemical analysis of different bone markers.
Measurement of different bone markers by biochemical analysis of blood samples.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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)
* Skin infection or severe skin affection in the measurement area of microindentation
* Chronic liver or gallbladder disease
* Current malignant disorders
* Former or current thyrotoxicosis (T4 over normal range ≥ 6 months)
* Cushing disease
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Odense University Hospital
OTHER
Hvidovre University Hospital
OTHER
Responsible Party
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Nicola Hepp
Principal Investigator, MD
Locations
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Hvidovre University Hospital
Hvidovre, Capital Region, Denmark
Countries
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References
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Herrera S, Diez-Perez A. Clinical experience with microindentation in vivo in humans. Bone. 2017 Feb;95:175-182. doi: 10.1016/j.bone.2016.11.003. Epub 2016 Nov 11.
Other Identifiers
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HvH-BABS-Study
Identifier Type: -
Identifier Source: org_study_id
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