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OpenTrials
Completed

NCT Number: NCT00745485

Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. Bone Mineral Density

    Time frame: at baseline and month 12

  2. Bone turnover

    Time frame: at baseline and month 12

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: LISA

Important dates

Study start
2008
Primary completion
2010
First posted
Sep 3, 2008
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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