The efficacy and safety of zoledronate in children and adolescents with chronic neurological conditions and osteoporosis: a crossover trial with long term follow up.

Not Applicable

Recruiting

• Conditions: Osteoporosis; Metabolic and Endocrine - Other metabolic disorders; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12610000281099
• Lead Sponsor: Princess Margaret Hospital for Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Children and adolescents eligible to participate in the study must be:
1. Diagnosed with a chronic neurological condition.
2. Aged = 4 years to < 18, inclusive
3. Have an increased risk of fractures as defined by BMD <-2.5 at one or more sites and, a history of at least one radiologically confirmed, non traumatic or low impact fracture and/or significant bone pain (as determined by appearing to be in pain after other causes of pain have been excluded)
4. Able and willing to participate in the study as evidenced by a parent/ legal guardian signing a valid written consent form.
5. All pre existing factors which could contribute to a reduction in BMD such as diet, sunlight exposure, anticonvulsant medication and weight bearing programme have been addressed 6 months prior to commencement of infusion.
6. If female, must have a negative serum pregnancy test at baseline and be using effective contraception if sexually active.

Exclusion Criteria

EXCLUSION CRITERIA
1. Body weight < 10kg.
2. History of cancer within past five years.
3. Untreated rickets within one year of treatment.
4. Documented history of an abnormal or allergic reaction to bisphosphonates.
5. Pubertal delay.
6. Clinically significant abnormal laboratory finding at screening
- Abnormal liver function tests – Alanine Amino Transferase (ALT) & Aspartate Amino Transferase (AST) > 2x upper limit of normal.
- Abnormal thyroid stimulating hormone (TSH) and/ or parathyroid hormone (PTH).
- Serum 25 (OH) vitamin D < 20 nmol/

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of zoledronate:<br>The efficacy of zoledronate will be assessed by the improvement in the participants bone mineral density (BMD) z score over time.[Time = 0<br>Time = 6 months<br>Time = 12 months<br>Time = 18 months<br>Time = 24 months<br>Time = 30 months];Fracture rate<br>Number of new fractures during the study period will be collected. Fracture will be diagnosed via x-ray.[Time = 0<br>Time = 6 months<br>Time = 12 months<br>Time = 18 months<br>Time = 24 months<br>Time = 30 months];Biochemical measures<br>Serum parathyroid hormone (PTH)<br>Urinary N-telopeptides[Time = 0<br>Time = 6 months<br>Time = 12 months<br>Time = 18 months<br>Time = 24 months<br>Time = 30 months]