NCT00745485

Brief Summary

  1. 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

September 1, 2008

Last Update Submit

February 23, 2017

Conditions

Osteoporosis

Keywords

Osteoporosiszoledronic acidpostmenopausal women

Outcome Measures

Primary Outcomes (2)

  • Bone Mineral Density

    at baseline and month 12

  • Bone turnover

    at baseline and month 12

Study Arms (1)

Zoldronic

EXPERIMENTAL
Drug: zoledronic acid

Interventions

zoledronic acidDRUG
Zoldronic

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • Intravenous bisphosphonate within the past 12 months
  • Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
  • Abnormal liver function tests greater than twice normal
  • Evidence of high bone turnover
  • Abnormal calcium blood levels
  • Low Vitamin D levels
  • Poor renal function
  • Abnormal parathyroid function or uncontrolled, abnormal thyroid function
  • History of eye inflammation
  • History of diabetes leading to kidney or eye problems
  • A history of cancer except some non-invasive cancers of skin, colon, breast and cervix
  • Patients with severe dental problems or current dental infections Or requiring dental surgery
  • Known sensitivity to zoledronic acid or bisphosphonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novartis Investigative Site

Blacktown, New South Wales, 2148, Australia

Location

Novartis Investigative Site

Georgetown, New South Wales, 2298, Australia

Location

Novartis Investigative Site

Leichhardt, New South Wales, 2040, Australia

Location

Novartis Investigative Site

Manly, New South Wales, 2095, Australia

Location

Novartis Investigative Site

North Parramatta, New South Wales, 2150, Australia

Location

Novartis Investigative Site

Wentworthville, New South Wales, 2150, Australia

Location

Novartis Investigative Site

Caloundra, Queensland, 4551, Australia

Location

Novartis Investigative Site

Southport, Queensland, 4215, Australia

Location

Novartis Investigative Site

Ashford, South Australia, 5035, Australia

Location

Novartis Investigative Site

Norwood, South Australia, 5067, Australia

Location

Novartis Investigative Site

Footscray, Victoria, 3011, Australia

Location

Novartis Investigative Site

Ringwood, Victoria, 3134, Australia

Location

Novartis Investigative Site

Nedlands, WA 6009, Australia

Location

Novartis Investigative Site

Nedlands Perth, 6009, Australia

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2010

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

AU(14)