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

Phase 4

• Conditions: cerebral palsy; osteoporosis; Musculoskeletal - Osteoporosis; Neurological - Other neurological disorders

• Registration Number: ACTRN12615001048572
• Lead Sponsor: Anne Trinh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in bone mineral density as measured by dual energy xray absorptiometry (DXA)[12 and 24 months]

Secondary Outcome Measures

Name	Time	Method
changes in bone density as measured by high resolution peripheral quantitative computed tomography (HR-pQCT)[12 and 24 months];Changes in bone turnover markers (serum ALP, CTX, P1NP -all assessed through blood samples)[12 and 24 months]