Zoledronate against fractures in children with cerebral palsy

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10049088Term: OsteopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 15.1Level: HLTClassification code 10034157Term: Pathological fractures and complicationsSystem Organ Class: 100000005035; MedDRA version: 20.0Level: PTClassification code 10049904Term: Osteoporosis prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10021740Term: Infantile cerebral palsySystem Organ Class: 100000012650; MedDRA version: 20.0Level: PTClassification code 10006002Term: Bone painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10013522Term: Disuse osteoporosisSystem Organ Class: 100000018618; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; cerebral palsy, osteopenia, fracture

• Registration Number: EUCTR2014-002118-21-DK
• Lead Sponsor: Randers Regional Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Child age 5-17 years
Cerebral palsy GMFCS level 4 or 5
Bone Mass Density z-score below -1
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous treatment with any disphosphonate
Inability to receive medication via i.v. route
Hydroxy-vitamin D level below 50
Bone metabolic disease
Liver/kidney disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of 12 months treatment with i.v. zoledronic acid on bone mineralization in children with non-ambulatory cerebral palsy.;Secondary Objective: To evaluate the effect of 12 months treatment with i.v. zoledronic acid on fractures, pain and quality of life in children with non-ambulatory cerebral palsy.;Primary end point(s): Bone Mass Density z-score change;Timepoint(s) of evaluation of this end point: 0 days<br>1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain score change<br>Well-being score change<br>Fracture occurence;Timepoint(s) of evaluation of this end point: 0 days<br>1 year<br>