OsteoporosisPhase 3NCT00097812
Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid
A Phase 3 study testing zoledronic acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 13 sites in 2 countries.
Trial summary
The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate. Read more about this study
- Who is it for?
- Ages 45 to 79 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zoledronic acid
- How many people
- 220 participants
- Where
- 13 sitesin 2 countries
- Study dates
- May 2004to Dec 2005
- Phase
- Phase 3
- 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 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
- Treatment with oral bisphosphonate for at least 1 year
Who cannot join
- Any woman of child bearing potential
- Treatment with other bone active agents
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Florida Medical Research Institute
Gainsville, Florida, 32605
University of Kansas School of Medicine/ Division of Endocrinology
Kansas City, Kansas, 66160
Colorado Center for Bone Research
Lakewood, Colorado, 80227
Arthritis Center of Nebraska
Lincoln, Nebraska, 68516
Creighton University Osteoporosis Research Center
Omaha, Nebraska, 68131
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Osteoporosis Center
Portland, Oregon, 97213
The Permanente Medical Group
Santa Rosa, California, 95403
Puget Sound Osteoporosis Center
Seattle, Washington, 98144
Radiant Research
Stuart, Florida, 34996
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
Radiant Research
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.
- Conditions
- Osteoporosis
- Being tested
- zoledronic acid
- Keywords
- osteoporosis, osteopenia, post-menopausal, zoledronic acid
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations
Secondary outcomes (3)
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2004 (estimated)
- Study startMay 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097812
- Sponsor's protocol ID
- CZOL446H2313
- Status last verified
- Apr 2012
- First submitted
- 30 Nov 2004
- Last updated
- 27 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
- ClinicalTrials.gov ID
- NCT00097812
- Acronym / sponsor ID
- CZOL446H2313
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, osteopenia, post-menopausal, zoledronic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Dec 2004 (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 purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-menopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
- Treatment with oral bisphosphonate for at least 1 year
Key exclusion criteria (3 listed)
- Any woman of child bearing potential
- Treatment with other bone active agents
- Other protocol-defined inclusion/exclusion criteria may apply.
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 | – |
Primary outcome
To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations
3 secondary outcomes
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire
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 27 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zoledronic acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 13 sites in 2 countries.
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 3 inclusion and 3 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations. 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 27 Apr 2012.