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CompletedNCT00745485LISAUpdated Feb 27, 2017

Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

A Phase 4 interventional study of zoledronic acid in Osteoporosis, sponsored by Novartis Pharmaceuticals. Completed at 14 sites in Australia. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2017-02-27.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
70 Years and older
Sex
Female
01

Study 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.
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Conditions studied

  • Osteoporosis

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Keywords

  • Osteoporosis
  • zoledronic acid
  • postmenopausal women
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 186 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    Zoldronic

    Drug: zoledronic acid

Interventions

  • Drugzoledronic acid
06

What researchers measure

Primary outcomes

  1. Bone Mineral Density

    Time frame: at baseline and month 12

  2. Bone turnover

    Time frame: at baseline and month 12

07

Study locations

14 sites
  • Novartis Investigative Site
    Blacktown, New South Wales 2148, Australia
  • Novartis Investigative Site
    Georgetown, New South Wales 2298, Australia
  • Novartis Investigative Site
    Leichhardt, New South Wales 2040, Australia
  • Novartis Investigative Site
    Manly, New South Wales 2095, Australia
  • Novartis Investigative Site
    North Parramatta, New South Wales 2150, Australia
  • Novartis Investigative Site
    Wentworthville, New South Wales 2150, Australia
  • Novartis Investigative Site
    Caloundra, Queensland 4551, Australia
  • Novartis Investigative Site
    Southport, Queensland 4215, Australia
  • Novartis Investigative Site
    Ashford, South Australia 5035, Australia
  • Novartis Investigative Site
    Norwood, South Australia 5067, Australia
  • Novartis Investigative Site
    Footscray, Victoria 3011, Australia
  • Novartis Investigative Site
    Ringwood, Victoria 3134, Australia
  • Novartis Investigative Site
    Nedlands Perth, 6009, Australia
  • Novartis Investigative Site
    Nedlands, WA 6009, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00745485
Lead sponsor
Novartis Pharmaceuticals
First posted
Sep 3, 2008
Start date
Aug 2008
Primary completion
Jul 2010
Last update
Feb 27, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
Novartis Pharmaceuticals
principal investigator · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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