Zoledronic acid to improve low bone mineral density in non-ambulatory adults with cerebral palsy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001048572

Enrollment

Registered

2015-10-07

Start date

2016-02-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Broken bones and thin bones are common in people with cerebral palsy. This is due to a number of factors including reduced activity and standing, poor nutrition, use of medications for epilepsy and reduced sex hormones. Thin bones are becoming more of a problem as adults with cerebral palsy are getting older. In older women and men with thin bones, there are good drug treatments available to reduce their risk of breaking a bone. One such treatment is zoledronic acid, which is given as an intravenous infusion once a year. This drug is currently being used and registered in Australia for treatment of osteoporosis (thin bones) in older women and men. The aim of this study is to see if zoledronic acid can be used in adults with cerebral palsy to improve their bone strength and reduce their risk of breaking bones. This drug has not be used in a study of adults with cerebral palsy before.

Interventions

4mg zoledronic acid (intravenous) to be given as a once off infusion Calcium supplementation: 1000mg daily orally/via PEG Vitamin D supplementation: 2000 international units daily orally/via PEG Calcium and vitamin D supplementation will commence prior to infusion to ensure adequate levels and reduction of side effects Laboratory testing will be performed to determine if vitamin D supplementation is adequate

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

aged greater or equal to 18 years cerebral palsy non ambulatory (includes those who can stand for transfers only). Z score at lumbar spine or proximal femur less or equal to -2.0

Exclusion criteria

- Secondary cause for bone disease (hypoparathyroidism, hyperparathyroidism, hypothyroidism, hyperthyroidism, rheumatoid arthritis, Paget’s disease - Hypocalcaemia/hypercalcaemia - Previous use of bisphosphonates in the last 2 years - Current use of medication to treat osteoporosis: strontium, denosumab - Use of glucocorticoids (washout period of 1 year) - Calculated creatinine clearance of <30ml/min as per Cockcroft Gault equation - Pregnancy (F) - Post-menopausal (F) - Current use of medications that can increase risk of renal dysfunction: diuretics, aminoglycosides

Outcome results