Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Children Clinical Trial

— Bisphosphonate  

Official title:

Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012320
• Other study ID #: Local/2018/TAT-01
• Status: Completed
• Start date: October 31, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Events
• Bisphosphonate-Associated Osteonecrosis
• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Bone Fragile
• Children
• Osteonecrosis

Intervention

Other:
• No intervention, observational study
No intervention, observational study

Locations

Country	Name	City	State
France	CHUNimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fracture rates	(numbers)	2 years
Primary	bone mineral density	(Z-score)	2 years
Primary	pain frequency	(never, occasional, regular)	2 years