WithdrawnPhase 4ACTRN12609000278235
The effect of zoledronate on cardiovascular protection in osteoporotic elderly patients who have suffered a hip fracture.
A randomised, double-blind, placebo-controlled trial to determine the effect of zoledronate on endothelial dysfunction in osteoporotic elderly patients who have suffered a hip fracture
Sponsor
A/Prof. Gustavo Duque
Enrollment
60 participants
Start Date
Jun 1, 2009
Study Type
Interventional
Conditions
Summary
This is a one year study to identify the effect of Zoledronate on endothelial dysfunction, a marker or cardiovascular risk.
Eligibility
Sex: Both males and femalesMin Age: 65 YearssMax Age: 100 Yearss
Inclusion Criteria2
- - Diagnosis of osteoporosis based on bone mineral density (BMD)
- - Previous history of hip fracture a year prior to the administration of the dose
Exclusion Criteria8
- 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
- Hypothyroidism, not appropriately controlled with long-term thyroxine therapy
- Serum 25-hydroxyvitamin D concentrations <15 ng/L
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Interventions
Zoledronic acid 5 mg in 100 mL, intravenous, infused over 30 minutes, single dose.
Zoledronic acid 5 mg in 100 mL, intravenous, infused over 30 minutes, single dose.
Locations(1)
View Full Details on ANZCTR
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ACTRN12609000278235
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