- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181164
Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP) (BABS)
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Capital Region
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Hvidovre, Capital Region, Denmark, 2650
- Hvidovre University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria HPP-Group:
- 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
Inclusion Criteria Control-Group:
- 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 HPP-Group:
- 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
Exclusion Criteria Control-Group:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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HPP-Group
Adults with hypophosphatasia.
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Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.
HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.
Measurement of different bone markers by biochemical analysis of blood samples.
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Control-Group
Healthy control subjects.
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Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.
HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.
Measurement of different bone markers by biochemical analysis of blood samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Bone Mineral Strength Index (BMSi) between the two groups, assessed by microindentation (OsteoProbe®).
Time Frame: 1. October 2019 - 31.July 2020
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Differences in BMSi between the HPP- and Control-Group will be evaluated by microindentation (OsteoProbe®). Microindentation is a technology directly measuring bone strength by a minimal invasive technique. By applying a standardized pressure with a probe, which at the same time measures the indentation depth in the tibia bone, a measure of bone strength is obtained and calculated as Bone Mineral Strength Index (BMSi) [1]. |
1. October 2019 - 31.July 2020
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between BMSi and fracture prevalence in the HPP-Group and the Control-Group.
Time Frame: 1. October 2019 - 31.July 2020
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BMSi will be evaluated by microindentation (described above).
In addition, information about the occurrence of fractures in the HPP- and Control-Group will be obtained by data from the Danish National Patient Register and a structured clinical interview.
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1. October 2019 - 31.July 2020
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Evaluation of differences in bone microarchitecture between the HPP- and Control-Group by high resolution peripheral quantitative computed tomography (HRpQCT).
Time Frame: 1. October 2019 - 31.July 2020
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To asses differences in bone architecture between the two groups, the non-dominant distal radius and non-dominant distal tibia will be examined by HRpQCT, which will provide data about total, trabecular and cortical BMD, trabecular thickness, cortical thickness, trabecular number, stiffness and finite element failure load of the radius and tibia.
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1. October 2019 - 31.July 2020
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Evaluation of differences in bone homeostasis between the two groups by biochemical analysis of different bone markers (P1NP, CTx, BALP, Trab-5, Sclerostin, Osteocalcin and FGF23)
Time Frame: 1. October 2019 - 31.July 2020
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Blood samples will be collected for biochemical analysis of different bone markers (P1NP, CTx, BALP, Trab-5, Sclerostin, Osteocalcin and FGF23). BALP = Bone specific alkaline phosphatase CTx = Carboxy-terminal collagen crosslinks FGF-23 = Fibroblast growth factor 23 P1NP = Procollagen type 1 amino-terminal propeptide Trab-5 = Tartrate-resistant acid phosphatase-5 |
1. October 2019 - 31.July 2020
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HvH-BABS-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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