Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745485

Acronym

LISA

Enrollment

186

Registered

2008-09-03

Start date

2008-08-31

Completion date

Unknown

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, zoledronic acid, postmenopausal women

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.

Interventions

DRUGzoledronic acid

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

70 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density	at baseline and month 12
Bone turnover	at baseline and month 12

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026