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

Novartis

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745485

CZOL446HAU27

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: Female

Ages: 70+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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186 participants in 1 patient group

Zoldronic

Experimental group

Treatment:

Drug: zoledronic acid