Status:
COMPLETED
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Osteoporosis
Eligibility:
FEMALE
70+ years
Phase:
PHASE4
Brief Summary
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 servic...
Eligibility Criteria
Inclusion
- 1\. Female after menopause with osteoporosis either: 70 years of age or older with a bone mineral density T-score of -3.0 or less OR with a fracture due to minimal trauma.
Exclusion
- Intravenous bisphosphonate within the past 12 months
- Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
- Abnormal liver function tests greater than twice normal
- Evidence of high bone turnover
- Abnormal calcium blood levels
- Low Vitamin D levels
- Poor renal function
- Abnormal parathyroid function or uncontrolled, abnormal thyroid function
- History of eye inflammation
- History of diabetes leading to kidney or eye problems
- A history of cancer except some non-invasive cancers of skin, colon, breast and cervix
- Patients with severe dental problems or current dental infections Or requiring dental surgery
- Known sensitivity to zoledronic acid or bisphosphonates
- Other protocol defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00745485
Start Date
August 1 2008
Last Update
February 27 2017
Active Locations (14)
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1
Novartis Investigative Site
Blacktown, New South Wales, Australia, 2148
2
Novartis Investigative Site
Georgetown, New South Wales, Australia, 2298
3
Novartis Investigative Site
Leichhardt, New South Wales, Australia, 2040
4
Novartis Investigative Site
Manly, New South Wales, Australia, 2095