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

• Conditions: Hypophosphatasia (HPP)
• Interventions: Other: Microindentation; Other: High resolution peripheral quantitative computed tomography (HRpQCT); Biological: Biochemical analysis of different bone markers.

• Registration Number: NCT04181164
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-11-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HPP-Group	Microindentation	Adults with hypophosphatasia.
HPP-Group	High resolution peripheral quantitative computed tomography (HRpQCT)	Adults with hypophosphatasia.
Control-Group	Biochemical analysis of different bone markers.	Healthy control subjects.
HPP-Group	Biochemical analysis of different bone markers.	Adults with hypophosphatasia.
Control-Group	Microindentation	Healthy control subjects.
Control-Group	High resolution peripheral quantitative computed tomography (HRpQCT)	Healthy control subjects.

Primary Outcome Measures

Name	Time	Method
Differences in Bone Mineral Strength Index (BMSi) between the two groups, assessed by microindentation (OsteoProbe®).	1. October 2019 - 31.July 2020	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) \[1\].

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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
Correlation between BMSi and fracture prevalence in the HPP-Group and the Control-Group.	1. October 2019 - 31.July 2020	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.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Capital Region, Denmark