Postmenopausal OsteoporosisPhase 3NCT00909961
A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years
A Phase 3 study testing Zoledronic acid in people with Postmenopausal Osteoporosis, run by Novartis Pharmaceuticals at 6 sites in Turkey (Türkiye).
Trial summary
This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Nov 2009to 16 Dec 2011
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal osteoporosis
- Patients who has a low bone mineral density at hip or vertebral
- Patients who has an osteoporotic fracture at hip or vertebra
Who cannot join
- Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
- Known metabolic bone disease excluding osteoporosis.
- Serious systemic disorder treated with drugs interfering with bone metabolism.
- Significant liver or renal failure
- Pathologic fracture in the examined body area or elsewhere.
- Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
- Patients with hypocalcaemia
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Novartis Investigational site
Ankara
Novartis Investigative site
Antalya
Novartis Investigational site
Istanbul
Novartis Investigative site
Izmir
Novartis Investigative site
Kayseri
Novartis Investigative site
Konya
About this study
Official title: A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years
This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Zoledronic acid
- Keywords
- Osteoporosis, Bone Mineral Density, Biomarkers
- 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
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Experimental | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - BMD
Measured: 1 year
Secondary outcomes (2)
Efficacy - Biochemical markers
Measured: 6 months
Safety - Rate of adverse events and serious adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completion16 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909961
- Sponsor's protocol ID
- CZOL446HTR04
- Status last verified
- Mar 2017
- First submitted
- 28 May 2009
- Last updated
- 21 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years
- ClinicalTrials.gov ID
- NCT00909961
- Acronym / sponsor ID
- CZOL446HTR04
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Osteoporosis, Bone Mineral Density, Biomarkers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- 16 Dec 2011 (actual)
- First posted
- 29 May 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.
This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Experimental | Drug: Zoledronic acid |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal osteoporosis
- Patients who has a low bone mineral density at hip or vertebral
- Patients who has an osteoporotic fracture at hip or vertebra
Key exclusion criteria (8 listed)
- Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
- Known metabolic bone disease excluding osteoporosis.
- Serious systemic disorder treated with drugs interfering with bone metabolism.
- Significant liver or renal failure
- Pathologic fracture in the examined body area or elsewhere.
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 |
Primary outcome
Efficacy - BMD
Time frame: 1 year
2 secondary outcomes
Efficacy - Biochemical markers
Time frame: 6 months
Safety - Rate of adverse events and serious adverse events
Time frame: 6 months
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 21 Mar 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 1 country: 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 Postmenopausal Osteoporosis, run by Novartis Pharmaceuticals at 6 sites in Turkey (Türkiye).
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 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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?
Efficacy - BMD (time frame: 1 year). 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 21 Mar 2017.