Zoledronate against fractures in children with cerebral palsy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002118-21-DK

Enrollment

Unknown

Registered

2014-10-01

Start date

2017-03-17

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral palsy, osteopenia, fracture MedDRA version: 20.0 Level: PT Classification code 10049088 Term: Osteopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.1 Level: HLT Classification code 10034157 Term: Pathological fractures and complications System Organ Class: 100000005035 MedDRA version: 20.0 Level: PT Classification code 10049904 Term: Osteoporosis prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA

Interventions

Trade Name: Zoledronsyre ”Fresenius Kabi” Product Name: zoledronate Product Code: zol Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Numb

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 1 year	—

Measure

Time frame

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 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Pain score change Well-being score change Fracture occurence;Timepoint(s) of evaluation of this end point: 0 days 1 year	—

Countries

Denmark

Contacts

Public ContactResearch Unit

Randers Regional Hospital

zol.mod.brud@gmail.com457842 0172

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026