OsteopeniaPhase 3NCT00145275
To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
A Phase 3 study testing zoledronic acid in people with Osteopenia, run by Novartis at 10 sites in 5 countries.
Trial summary
Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- zoledronic acid
- How many people
- 455 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Dec 2004to Oct 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 75 years
- Women only
- Adult, Older adult
Who may be able to join
- Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
- Low bone mineral density
Who cannot join
- Certain prior treatments for low bone mass/osteopenia
- Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation
- Impaired kidney function
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
United States6 sites
Study site
Unavailable, Georgia
Study site
Unavailable, Illinois
Study site
Unavailable, Indiana
Study site
Unavailable, Iowa
Study site
Unavailable, Kansas
Study site
Unavailable, Washington
About this study
Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.
- Conditions
- Osteopenia
- Being tested
- zoledronic acid
- Keywords
- zoledronic acid, bisphosphonate, Low bone mass
- Medical subject headings
- 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.
Temperature increase
Secondary outcomes (2)
Questionnaires
VAS (visual analog scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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
- 455 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145275
- Sponsor's protocol ID
- CZOL446H2407
- Status last verified
- Apr 2012
- First submitted
- 1 Sep 2005
- 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
- To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT00145275
- Acronym / sponsor ID
- CZOL446H2407
- Conditions
- Osteopenia
- Keywords
- zoledronic acid, bisphosphonate, Low bone mass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 5 Sep 2005 (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.
Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
- Low bone mineral density
Key exclusion criteria (4 listed)
- Certain prior treatments for low bone mass/osteopenia
- Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation
- Impaired kidney function
- 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
Temperature increase
2 secondary outcomes
Questionnaires
VAS (visual analog scale)
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.
10 sites in 5 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 Osteopenia, run by Novartis at 10 sites in 5 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 2 inclusion and 4 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 10 sites in United States, Australia, Canada, Russia, South Africa. 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?
Temperature increase. 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.