Clinical trial NCT00745485: Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid
Official title: A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Osteoporosis
zoledronic acid
postmenopausal women
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 186
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Bone Mineral Density
timeFrame: at baseline and month 12
measure: Bone turnover
timeFrame: at baseline and month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Georgetown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Leichhardt
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Manly
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: North Parramatta
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Wentworthville
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Caloundra
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Southport
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Ashford
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Norwood
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Footscray
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Ringwood
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands Perth
country: Australia
facility: Novartis Investigative Site
city: Nedlands
country: Australia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References: