Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

Osteoporosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745485
• Other study ID #: CZOL446HAU27
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2008
• Last updated: February 23, 2017
• Start date: August 2008

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• zoledronic acid

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Ashford	South Australia
Australia	Novartis Investigative Site	Blacktown	New South Wales
Australia	Novartis Investigative Site	Caloundra	Queensland
Australia	Novartis Investigative Site	Footscray	Victoria
Australia	Novartis Investigative Site	Georgetown	New South Wales
Australia	Novartis Investigative Site	Leichhardt	New South Wales
Australia	Novartis Investigative Site	Manly	New South Wales
Australia	Novartis Investigative Site	Nedlands
Australia	Novartis Investigative Site	Nedlands Perth
Australia	Novartis Investigative Site	North Parramatta	New South Wales
Australia	Novartis Investigative Site	Norwood	South Australia
Australia	Novartis Investigative Site	Ringwood	Victoria
Australia	Novartis Investigative Site	Southport	Queensland
Australia	Novartis Investigative Site	Wentworthville	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density		at baseline and month 12
Primary	Bone turnover		at baseline and month 12

External Links

•   Results for CZOL446HAU27 from the Novartis Clinical Trials website