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

February 23, 2017 updated by: Novartis Pharmaceuticals

A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis

  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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Nedlands, Australia, WA 6009
        • Novartis Investigative Site
      • Nedlands Perth, Australia, 6009
        • Novartis Investigative Site
    • New South Wales
      • 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
        • Novartis Investigative Site
    • Queensland
      • Caloundra, Queensland, Australia, 4551
        • Novartis Investigative Site
      • Southport, Queensland, Australia, 4215
        • Novartis Investigative Site
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Novartis Investigative Site
      • Norwood, South Australia, Australia, 5067
        • Novartis Investigative Site
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Novartis Investigative Site
      • Ringwood, Victoria, Australia, 3134
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoldronic
Drug: zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density
Time Frame: at baseline and month 12
at baseline and month 12
Bone turnover
Time Frame: at baseline and month 12
at baseline and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446HAU27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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