Post-Menopausal OsteoporosisIVORYNCT00984893
Intra-venous Zoledronic Acid Once Yearly
An observational study of Post-Menopausal Osteoporosis, run by Novartis Pharmaceuticals at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Post-Menopausal Osteoporosis
- What is being tested?
- zoledronic acid and Any oral bisphosphonates marketed in Canada
- Type of treatment
- Pill or oral medicine
- How many people
- 1,551 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2008to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Study site
Hamilton, Ontario
Groupe de recherche en rhumatologie et maladies osseuses Inc
Québec, Quebec
Study site
Vancouver, British Columbia
About this study
Official title: A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates
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.
- Conditions
- Post-Menopausal Osteoporosis
- Being tested
- zoledronic acid, Any oral bisphosphonates marketed in Canada
- Keywords
- Osteoporosis, Bone Mineral density, fragility fractures, zoledronic acid., Treatment
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Any oral bisphosphonates marketed in CanadaDrug
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Not described Receives: Drug: zoledronic acid | |
| Oral Bisphosphonates | Not described Receives: Drug: Any oral bisphosphonates marketed in Canada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
Measured: 4 years
Secondary outcomes (5)
change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)
Measured: 4 years
change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
Measured: 4 years
Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
Measured: 4 years
Risk for fractures
Measured: 4 years
Burden of illness, health care resource utilization, and loss of productivity
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Menopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Vaillancourt, Study director, Novartis Pharmaceuticals Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984893
- Sponsor's protocol ID
- CZOL446HCA10
- Acronym
- IVORY
- Status last verified
- Mar 2016
- First submitted
- 23 Sep 2009
- Last updated
- 4 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates
- ClinicalTrials.gov ID
- NCT00984893
- Acronym / sponsor ID
- IVORY / CZOL446HCA10
- Conditions
- Post-Menopausal Osteoporosis
- Keywords
- Osteoporosis, Bone Mineral density, fragility fractures, zoledronic acid., Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,551 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | – | Drug: zoledronic acid |
| Oral Bisphosphonates | – | Drug: Any oral bisphosphonates marketed in Canada |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zoledronic acid | Drug | Zoledronic acid |
| Any oral bisphosphonates marketed in Canada | Drug | Oral Bisphosphonates |
Primary outcome
Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
Time frame: 4 years
5 secondary outcomes
change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)
Time frame: 4 years
change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
Time frame: 4 years
Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
Time frame: 4 years
Risk for fractures
Time frame: 4 years
Burden of illness, health care resource utilization, and loss of productivity
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
Related trials for Post-Menopausal Osteoporosis
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Post Menopausal Osteoporosis
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The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Postmenopausal Osteoporosis, Postmenopausal Osteopenia
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Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
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Sequential Therapies After Osteoanabolic Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Vaillancourt study director
Novartis Pharmaceuticals Canada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Menopausal Osteoporosis, run by Novartis Pharmaceuticals at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.