NCT01788267

Brief Summary

Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age. Recent data from our center and others have suggested that low BMD could be observed very early in life. However, quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength). High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology with very high spatial resolution. Images obtained with this technic are considered as virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces exploration in a three-dimensional manner, and therefore provides informations on bone microarchitecture as well as bone density. The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

February 5, 2013

Last Update Submit

May 23, 2019

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisHigh-Resolution peripheral Quantitative Computed TomographyBone Mass Density

Outcome Measures

Primary Outcomes (1)

  • Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography

    at the inclusion visit J0

Secondary Outcomes (3)

  • total radial bone mass density

    at the inclusion visit J0

  • Trabecular bone micro-architecture at tibia and radial sites

    at the inclusion visit J0

  • Biological markers : 1) bone markers : parathyroid hormone (PTH), Calcifediol (25(OH)D3), osteocalcin, Endocrinal markers : IGF-1 (insulin like growth factor ), IGFBP-3, leptin, adiponectin, visfatin, resistin

    at the inclusion visit J0

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

Volunteers realize a HR-pQCT scanner

Other: scan examination HR-pQCT

Cystic Fibrosis patient

EXPERIMENTAL

Patients realize a HR-pQCT scanner

Other: scan examination HR-pQCT

Interventions

scan examination HR-pQCTOTHER
Cystic Fibrosis patientHealthy volunteers

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cystic Fibrosis patient of both sex
  • Pubertal patient
  • Age ≥10 years and ≤18 years on the date of informed consent
  • FEV1(forced expiratory volume at one second ) ≥ 60% of predicted normal for age, gender and height
  • Patient on a clinical stable period

You may not qualify if:

  • Unable to maintain arm and/or leg immobile for 3 minutes
  • History of solid organ transplantation
  • Participation in the same time to a clinical trial
  • Acute pulmonary exacerbation at the time of evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme-Mère-Enfant

Bron, 69677, France

Location

Related Publications (1)

  • Braun C, Bacchetta J, Braillon P, Chapurlat R, Drai J, Reix P. Children and adolescents with cystic fibrosis display moderate bone microarchitecture abnormalities: data from high-resolution peripheral quantitative computed tomography. Osteoporos Int. 2017 Nov;28(11):3179-3188. doi: 10.1007/s00198-017-4179-9. Epub 2017 Aug 9.

    PMID: 28795206RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 11, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 28, 2019

Record last verified: 2015-05

Locations

FR(1)