search
Back to results

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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, zoledronic acid, postmenopausal women

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoldronic

Arm Description

Outcomes

Primary Outcome Measures

Bone Mineral Density
Bone turnover

Secondary Outcome Measures

Full Information

First Posted
September 1, 2008
Last Updated
February 23, 2017
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00745485
Brief Title
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid
Acronym
LISA
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, zoledronic acid, postmenopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoldronic
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
Bone Mineral Density
Time Frame
at baseline and month 12
Title
Bone turnover
Time Frame
at baseline and month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Novartis Investigative Site
City
Georgetown
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Novartis Investigative Site
City
Leichhardt
State/Province
New South Wales
ZIP/Postal Code
2040
Country
Australia
Facility Name
Novartis Investigative Site
City
Manly
State/Province
New South Wales
ZIP/Postal Code
2095
Country
Australia
Facility Name
Novartis Investigative Site
City
North Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Novartis Investigative Site
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Novartis Investigative Site
City
Caloundra
State/Province
Queensland
ZIP/Postal Code
4551
Country
Australia
Facility Name
Novartis Investigative Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Novartis Investigative Site
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novartis Investigative Site
City
Norwood
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Novartis Investigative Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Novartis Investigative Site
City
Ringwood
State/Province
Victoria
ZIP/Postal Code
3134
Country
Australia
Facility Name
Novartis Investigative Site
City
Nedlands Perth
ZIP/Postal Code
6009
Country
Australia
Facility Name
Novartis Investigative Site
City
Nedlands
ZIP/Postal Code
WA 6009
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

We'll reach out to this number within 24 hrs