1. The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study. 2. The study will pilot and test a Patient Registry and Infusion Service process, which will allow zoledronic acid to be administered to trial patients in the investigators' private rooms by a team of roving nurses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Novartis Investigative Site
Blacktown, New South Wales, Australia
Novartis Investigative Site
Georgetown, New South Wales, Australia
Novartis Investigative Site
Leichhardt, New South Wales, Australia
Bone Mineral Density
Time frame: at baseline and month 12
Bone turnover
Time frame: at baseline and month 12
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Novartis Investigative Site
Manly, New South Wales, Australia
Novartis Investigative Site
North Parramatta, New South Wales, Australia
Novartis Investigative Site
Wentworthville, New South Wales, Australia
Novartis Investigative Site
Caloundra, Queensland, Australia
Novartis Investigative Site
Southport, Queensland, Australia
Novartis Investigative Site
Ashford, South Australia, Australia
Novartis Investigative Site
Norwood, South Australia, Australia
...and 4 more locations