Intra-venous Zoledronic Acid Once Yearly (IVORY)
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00984893
First received: September 23, 2009
Last updated: April 23, 2012
Last verified: April 2012
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Purpose
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 | Intervention |
|---|---|
|
Post-Menopausal Osteoporosis |
Drug: zoledronic acid Drug: Any oral bisphosphonates marketed in Canada |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- change in hip BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Risk for fractures [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Burden of illness, health care resource utilization, and loss of productivity [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Zoledronic acid | Drug: zoledronic acid |
| Oral Bisphosphonates | Drug: Any oral bisphosphonates marketed in Canada |
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders 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
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984893
Locations
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada | |
| Canada | |
| Groupe de recherche en rhumatologie et maladies osseuses Inc | |
| Quebec, Canada | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Marc Vaillancourt | Novartis Pharmaceuticals Canada |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00984893 History of Changes |
| Other Study ID Numbers: | CZOL446HCA10 |
| Study First Received: | September 23, 2009 |
| Last Updated: | April 23, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Novartis:
|
Osteoporosis Bone Mineral density fragility fractures zoledronic acid. Treatment |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013