NCT04012320

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

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

October 31, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

July 9, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 14, 2019

Last Update Submit

July 8, 2019

Conditions

Bone FragileBisphosphonate-Associated OsteonecrosisChildrenAdverse Events

Outcome Measures

Primary Outcomes (3)

  • fracture rates

    (numbers)

    2 years

  • bone mineral density

    (Z-score)

    2 years

  • pain frequency

    (never, occasional, regular)

    2 years

Study Arms (2)

Pamidronate therapy

Other: No intervention, observational study

Zoledronate therapy

Other: No intervention, observational study

Interventions

No intervention, observational studyOTHER

No intervention, observational study

Pamidronate therapyZoledronate therapy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • be over 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUNimes

Nîmes, France

Location

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

Observation

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesJaw DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

July 9, 2019

Study Start

October 31, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 9, 2019

Record last verified: 2019-06

Locations

FR(1)