Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Completed

• Conditions: Bone Fragile; Children; Bisphosphonate-Associated Osteonecrosis; Adverse Events
• Interventions: Other: No intervention, observational study

• Registration Number: NCT04012320
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 available

Study Timeline

• Study Start: 2018-10-31
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-06
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pamidronate therapy	No intervention, observational study	-
Zoledronate therapy	No intervention, observational study	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHUNimes; 🇫🇷 Nîmes, France