CClinicalTrials.gg
CompletedNCT00984893IVORYUpdated Mar 4, 2016

Intra-venous Zoledronic Acid Once Yearly

An observational study in Post-Menopausal Osteoporosis, sponsored by Novartis Pharmaceuticals. Completed at 3 sites in Canada. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2016-03-04.

Sponsored by Novartis Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,551
Ages
45 Years and older
Sex
Female
01

Study summary

The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.

02

Conditions studied

  • Post-Menopausal Osteoporosis

Keywords

  • Osteoporosis
  • Bone Mineral density
  • fragility fractures
  • zoledronic acid.
  • Treatment
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 1,551 is above the median of 174 across 446 observational 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
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ambulatory Female patients, at least 45 years of age, diagnosed with osteoporosis and taking either Zelodronic acid or any other oral bisphosphonates (OBP) as per the current Canadian monograph

Inclusion criteria

  • Patient is an ambulatory female 45 years of age or older
  • Postmenopausal women with diagnosis of osteoporosis
  • Prescription of zoledronic acid or any OBP as per the current Canadian monograph
  • Must provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Any prior use of iv bisphosphonates within the last 2 years
  • Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)
  • Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..
  • Non-corrected hypocalcaemia at the time of zoledronic acid infusion
  • Creatinine clearance \< or = 30 ml/min
  • Unwillingness or inability to comply with the study requirements
  • Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,551 participants (actual)

Groups and cohorts

  • Zoledronic acid

    Drug: zoledronic acid

  • Oral Bisphosphonates

    Drug: Any oral bisphosphonates marketed in Canada

Interventions

  • Drugzoledronic acid
  • DrugAny oral bisphosphonates marketed in Canada
06

What researchers measure

Primary outcomes

  1. Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

Secondary outcomes

  1. change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

  2. change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

  3. Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

  4. Risk for fractures

    Time frame: 4 years

  5. Burden of illness, health care resource utilization, and loss of productivity

    Time frame: 4 years

07

Study locations

3 sites
  • Vancouver, British Columbia, Canada
  • Hamilton, Ontario, Canada
  • Groupe de recherche en rhumatologie et maladies osseuses Inc
    Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00984893
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 25, 2009
Start date
Nov 2008
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Mar 4, 2016

Study contacts

Marc Vaillancourt
study director · Novartis Pharmaceuticals Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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