Efficacy and Safety on the Use of Bisphosphonates in Paediatrics (Bisphosphonate)

July 8, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France
        • CHUNimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pamidronate therapy
Other: No intervention, observational study
No intervention, observational study
Zoledronate therapy
Other: No intervention, observational study
No intervention, observational study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2018/TAT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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