NCT03169192

Brief Summary

The study will be conducted at Assiut university children hospital and it will include patients with history of repeated fractures due to mild or irrelevant trauma. Diagnosis will be established by biochemical tests, bone survey to exclude secondary causes followed by Dual Energy absorbiometry scan to detect bone density of selected cases then confirm our diagnosis by detection of gene mutations of Osteogenesis imperfecta during one and half year duration with starting zoledronic acid therapy during this duration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

May 25, 2017

Last Update Submit

May 25, 2017

Conditions

Bone Disease, Metabolic

Outcome Measures

Primary Outcomes (1)

  • Percentage of children diagnosed as osteogenesis imperfecta

    diagnosis based on molecular genetic study

    1 month

Study Arms (1)

Repeated fractures group

detection of gene mutations of osteogenesis imperfecta in single group of patients with repeated fractures then start treatment with zoledronic acid in doses children less than 5 years ( 0.025 milligram for each kilogram every 3 months for 18 months duration) children more than 5 years ( 0.05 milligram for each kilogram every 6 months for 18 months duration)

Drug: Zoledronic Acid

Interventions

Zoledronic AcidDRUG

intravenous injections once every 3 months

Repeated fractures group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any Infants or children from age of 1 month up to age of 18 years presented with History of repeated fractures (more than one)

You may qualify if:

  • Positive family history of fractures or stillbirths.
  • Results of biochemical tests correlate with osteogenesis imperfecta.
  • Low bone density.

You may not qualify if:

  • Presence of secondary causes of fractures.
  • Abnormalities of biochemical tests or hormonal profile.
  • Negative family history.
  • Fractures in same site each time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (4)

  • Folkestad L, Hald JD, Hansen S, Gram J, Langdahl B, Abrahamsen B, Brixen K. Bone geometry, density, and microarchitecture in the distal radius and tibia in adults with osteogenesis imperfecta type I assessed by high-resolution pQCT. J Bone Miner Res. 2012 Jun;27(6):1405-12. doi: 10.1002/jbmr.1592.

    PMID: 22407910RESULT

  • Cheung MS, Glorieux FH. Osteogenesis Imperfecta: update on presentation and management. Rev Endocr Metab Disord. 2008 Jun;9(2):153-60. doi: 10.1007/s11154-008-9074-4. Epub 2008 Apr 11.

    PMID: 18404382RESULT

  • Bachrach LK, Gordon CM; SECTION ON ENDOCRINOLOGY. Bone Densitometry in Children and Adolescents. Pediatrics. 2016 Oct;138(4):e20162398. doi: 10.1542/peds.2016-2398.

    PMID: 27669735RESULT

  • Phillipi CA, Remmington T, Steiner RD. Bisphosphonate therapy for osteogenesis imperfecta. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005088. doi: 10.1002/14651858.CD005088.pub2.

    PMID: 18843680RESULT

Biospecimen

Retention: SAMPLES WITH DNA

we collect blood samples of patients to detect COLLAGEN I AI gene and COLLAGEN 1 A2 gene

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Mohamed M El-tellawy, Professor

CONTACT

(+20) 01003486595eltellaey270@hotmail.com

Azza A El-tyeb, Professor

CONTACT

(+20) 01006863271azeltayeb@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

June 1, 2017

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)