NCT04181164|Unknown
Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)
BABS
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BABS
Sponsor study identifier
observational
30
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study aims to evaluate the bone architecture and bone strength in adults with Hypophosphatasia (HPP).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2019
Actual (reported)November 18, 2019
Actual (reported)November 29, 2019
Actual (reported)September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Differences in Bone Mineral Strength Index (BMSi) between the two groups, assessed by microindentation (OsteoProbe®).
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
Correlation between BMSi and fracture prevalence in the HPP-Group and the Control-Group.
1. October 2019 - 31.July 2020
Evaluation of differences in bone microarchitecture between the HPP- and Control-Group by high resolution peripheral quantitative computed tomography (HRpQCT).
1. October 2019 - 31.July 2020
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)
1. October 2019 - 31.July 2020
Adults with hypophosphatasia.
Healthy control subjects.
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.
Adults, diagnosed with HPP (genetic verified) (n=15), matched 1:1 in case of gender, age (± 5 years), BMI (± 3 kg/m2), postmenopausal status (± 2 years) with healthy controls.
Hvidovre University Hospital
Hvidovre, Capital Region, 2650, Denmark
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.
First Submitted
November 18, 2019
First Posted
November 29, 2019
Study Start
October 1, 2019
Actual (reported)Primary Completion
September 30, 2021
Estimated (date passed)Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
Measurement of different bone markers by biochemical analysis of blood samples.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 1, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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