Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

NCT ID: NCT00745485

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

Brief 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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zoldronic

Group Type: EXPERIMENTAL

zoledronic acid

Intervention Type: DRUG

Interventions

zoledronic acid

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Blacktown, New South Wales, 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

North Parramatta, New South Wales, Australia

Novartis Investigative Site

Wentworthville, New South Wales, Australia

Novartis Investigative Site

Caloundra, Queensland, Australia

Novartis Investigative Site

Southport, Queensland, Australia

Novartis Investigative Site

Ashford, South Australia, Australia

Novartis Investigative Site

Norwood, South Australia, Australia

Novartis Investigative Site

Footscray, Victoria, Australia

Novartis Investigative Site

Ringwood, Victoria, Australia

Novartis Investigative Site

Nedlands, , Australia

Novartis Investigative Site

Nedlands Perth, , Australia

Countries

Australia

Other Identifiers

CZOL446HAU27

Identifier Type: -

Identifier Source: org_study_id