Not Yet RecruitingPhase 4ACTRN12611000507987

A randomised, double-blind, one-year controlled trial comparing Aclasta (zoledronic acid) 5 mg intravenously (i/v) against placebo infusion in patients with anti-epileptic (AED) drug induced bone loss

A randomised, double-blind, one-year controlled trial comparing bone mineral density following treatment with Aclasta (zoledronic acid 5mg i/v) versus placebo infusion in patients with AED-induced bone loss


Sponsor

Melbourne Health

Enrollment

60 participants

Start Date

May 20, 2011

Study Type

Interventional

Conditions

Summary

The purpose of this study is to investigate whether Aclasta is effective in treating osteoporosis caused by AED use.


Eligibility

Sex: Both males and femalesMin Age: 30 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether an annual intravenous infusion of Aclasta (zoledronic acid), a bone-strengthening medication, can prevent or reverse bone loss caused by long-term anti-epileptic drug use. Anti-epileptic medications are known to weaken bones over time, increasing fracture risk, and this study aims to find out if zoledronic acid can counteract that effect.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

5mg dose of zoledronic acid in 100 mL solution administered intravenously at months 1 and 12 of the trial. All participants will then enter the open label extension at the 12 month visit (ie 12 months

5mg dose of zoledronic acid in 100 mL solution administered intravenously at months 1 and 12 of the trial. All participants will then enter the open label extension at the 12 month visit (ie 12 months after the initial day 1 visit of the first year of the trial), where both groups will receive zoledronic acid 5mg iv at this month 12 visit only; 600 mg of elemental calcium twice daily and 1000 international units daily of vitamin D for the duration of the trial being 2 years, beginning at day 1 in oral capsule form; Paracetamol 2x500 mg capsules every 6 hours for 3 days post each infusion.


Locations(1)

Australia

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ACTRN12611000507987