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Intra-venous Zoledronic Acid Once Yearly (IVORY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984893
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment
Post-Menopausal Osteoporosis Drug: zoledronic acid Drug: Any oral bisphosphonates marketed in Canada

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Study Type : Observational
Actual Enrollment : 1551 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates
Study Start Date : November 2008
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort Intervention/treatment
Zoledronic acid Drug: zoledronic acid
Oral Bisphosphonates Drug: Any oral bisphosphonates marketed in Canada

Primary Outcome Measures :
  1. Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984893

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Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Groupe de recherche en rhumatologie et maladies osseuses Inc
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Marc Vaillancourt Novartis Pharmaceuticals Canada
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00984893    
Other Study ID Numbers: CZOL446HCA10
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Bone Mineral density
fragility fractures
zoledronic acid.
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs