ActivePhase 4ACTRN12609000593235
Efficacy of Zoledronate in fracture prevention in osteopenic postmenopausal women.
Sponsor
Professor Ian Reid
Enrollment
2,000 participants
Start Date
Sep 28, 2009
Study Type
Interventional
Conditions
Summary
This study is to determine whether the administration of the bone strengthening drug Zoledronate will reduce the numbers of fractures occurring in women who have low bone density but whose densities are not low enough to be classified as having osteoporosis.
Eligibility
Sex: FemalesMin Age: 65 YearssMax Age: 85 Yearss
Inclusion Criteria4
- Female subjects only will be studied
- They must be >5years postmenopausal and aged >65 years
- Life expectancy >5years
- Total hip T-score <-1.0 and >-2.5 at either hip
Exclusion Criteria11
- Renal impairment (estimated Glomerular Filtration Rate <30 ml/minute)
- Untreated hypo or hyperthyroidism
- Active liver disease
- Concurrent major systemic disease
- Active malignancey (other than skin cancers) within the last 2 years or still requiring treatment (eg anti-estrogens)
- Metabolic bone disease
- Regular use of Hormone Replacement Therapy within the previous 1 year
- Treatment with bisphosphonates in the previous 1 year
- Current treatment with glucocorticoid drugs
- Regular use of other bone-active drugs in the previous year
- Bone Mineral Density of Lumbar spine (L1-4) <-3.0
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Interventions
Intravenous Zoledronate 5mg/100ml infused over 15 minutes every 18 months for 6 years (4 injections at Baseline, 18,36and 54 months)
Intravenous Zoledronate 5mg/100ml infused over 15 minutes every 18 months for 6 years (4 injections at Baseline, 18,36and 54 months)
Locations(1)
View Full Details on ANZCTR
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ACTRN12609000593235