Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid (LISA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00745485
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : February 27, 2017
Information provided by:

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 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: zoledronic acid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis
Study Start Date : August 2008
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zoldronic Drug: zoledronic acid

Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: at baseline and month 12 ]
  2. Bone turnover [ Time Frame: at baseline and month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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 Criteria:

  1. Intravenous bisphosphonate within the past 12 months
  2. Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
  3. Abnormal liver function tests greater than twice normal
  4. Evidence of high bone turnover
  5. Abnormal calcium blood levels
  6. Low Vitamin D levels
  7. Poor renal function
  8. Abnormal parathyroid function or uncontrolled, abnormal thyroid function
  9. History of eye inflammation
  10. History of diabetes leading to kidney or eye problems
  11. A history of cancer except some non-invasive cancers of skin, colon, breast and cervix
  12. Patients with severe dental problems or current dental infections Or requiring dental surgery
  13. Known sensitivity to zoledronic acid or bisphosphonates

Other protocol defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00745485

Australia, New South Wales
Novartis Investigative Site
Blacktown, New South Wales, Australia, 2148
Novartis Investigative Site
Georgetown, New South Wales, Australia, 2298
Novartis Investigative Site
Leichhardt, New South Wales, Australia, 2040
Novartis Investigative Site
Manly, New South Wales, Australia, 2095
Novartis Investigative Site
North Parramatta, New South Wales, Australia, 2150
Novartis Investigative Site
Wentworthville, New South Wales, Australia, 2150
Australia, Queensland
Novartis Investigative Site
Caloundra, Queensland, Australia, 4551
Novartis Investigative Site
Southport, Queensland, Australia, 4215
Australia, South Australia
Novartis Investigative Site
Ashford, South Australia, Australia, 5035
Novartis Investigative Site
Norwood, South Australia, Australia, 5067
Australia, Victoria
Novartis Investigative Site
Footscray, Victoria, Australia, 3011
Novartis Investigative Site
Ringwood, Victoria, Australia, 3134
Novartis Investigative Site
Nedlands Perth, Australia, 6009
Novartis Investigative Site
Nedlands, Australia, WA 6009
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals Identifier: NCT00745485     History of Changes
Other Study ID Numbers: CZOL446HAU27
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Novartis:
zoledronic acid
postmenopausal women

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs