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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00745485
First received: September 1, 2008
Last updated: February 1, 2012
Last verified: February 2012
  Purpose
  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 Intervention Phase
Osteoporosis
Drug: zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: at baseline and month 12 ] [ Designated as safety issue: Yes ]
  • Bone turnover [ Time Frame: at baseline and month 12 ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: August 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoldronic Drug: zoledronic acid

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745485

Locations
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
Australia
Novartis Investigative Site
Nedlands, Australia, WA 6009
Novartis Investigative Site
Nedlands Perth, Australia, 6009
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00745485     History of Changes
Other Study ID Numbers: CZOL446HAU27
Study First Received: September 1, 2008
Last Updated: February 1, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Osteoporosis
zoledronic acid
postmenopausal women

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

ClinicalTrials.gov processed this record on September 16, 2014