Efficacy and Safety on the Use of Bisphosphonates in Paed... | NCT04012320

Studies
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

NCT04012320

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jul 9, 2019Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Bone Fragile
Bisphosphonate-Associated Osteonecrosis
Children
Adverse Events

Interventions

No intervention, observational study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 14, 2019

First Submission Date that Met QC Criteria

Jul 8, 2019

First Posted Date

Jul 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2019

Last Update Posted Date

Jul 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pamidronate therapy			Other: No intervention, observational study
Zoledronate therapy			Other: No intervention, observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention, observational study	Other	No intervention, observational study	Pamidronate therapy Zoledronate therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fracture rates	(numbers)	2 years
bone mineral density	(Z-score)	2 years
pain frequency	(never, occasional, regular)	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be under 18 years of age
have been treated by intravenous bisphosphonates for primary or secondary osteoporosis

Exclusion Criteria:

be over 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All patients under 18 years old who started intravenous bisphosphonates for primary or secondary osteoporosis in paediatric departments of Montpellier and Nimes University Hospitals between January 2012 and August 2018 were included.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059266	Bisphosphonate-Associated Osteonecrosis of the Jaw

Ancestor Terms

ID	Term
D010020	Osteonecrosis
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D007571	Jaw Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided