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
Melbourne Health
60 participants
May 20, 2011
Interventional
Conditions
Summary
The purpose of this study is to investigate whether Aclasta is effective in treating osteoporosis caused by AED use.
Eligibility
Inclusion Criteria3
- Patients taking AED in standard doses for at least 2 years
- Bone mineral density Z score < -1.5 or T score < -2.0 (Hologic) at the lumbar spine, total hip or femoral neck; males aged 30 years or older, females postmenopausal and aged 50 years or older.
- Patients must be on a stable course of epileptic therapy and have stable disease at the time of screening (in the opinion of the treating epilepsy specialist).
Exclusion Criteria24
- Prevalent major low-trauma fractures
- Other secondary causes of osteoporosis/fractures
- Limited life expectancy
- Contraindications to i/v bisphosphonates
- Prior use of tibolone or raloxifene within the last 6 months
- Any prior use of PTH or sodium fluoride for more than 1 week; if used for < 1 week, washout period for PTH or sodium fluoride 6 months
- Prior exposure to anabolic steroids or growth hormone within 6 months of entry in the trial
- Prior use of strontium ranelate within 1 year
- Creatinine clearance < 35 ml/min
- Pre-existing hypocalcemia (must be treated by adequate intake of calcium and vitamin D before therapy with zoledronic acid)
- Active history of uveitis, iritis, or episcleritis
- Metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
- History of diabetes mellitus
- Active primary hyperparathyroidism or other metabolic bone disorder
- Hypothyroidism, not appropriately controlled with long-term thyroxine therapy
- Serum 25-hydroxyvitamin D concentrations < 50 nmol/L (may be re-assessed for inclusion after adequate vitamin D repletion)
- Any bisphosphonate therapy within the prior 2 years, except oral bisphosphonate for up to 2 weeks in total in the previous 2 years.
- Women of childbearing potential not using an effective contraception method as well as women who are breastfeeding
- Known sensitivity to study drug or class of study drug
- Patients with any severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- Use of any other investigational agent in the last 30 days
- Unable for any reason to complete the specified assessments to at least 12 months
- Inability to measure areal BMD at both the lumbar spine and at least one hip
- Current treatment with topiramate.
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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 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)
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ACTRN12611000507987