OsteoporosisPhase 3NCT00097825
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
A Phase 3 study testing Zoledronic Acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 26 sites in 3 countries.
Trial summary
The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements. Read more about this study
- Who is it for?
- Ages 25 to 85 years, men only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Zoledronic Acid
- How many people
- 288 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Apr 2004to Aug 2007
- 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 25 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, 25-85 years old
Who cannot join
- Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
- History of severe liver, kidney or eye disease
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States16 sites
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106
St. Joseph Hospital
Bangor, Maine, 04401
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
UC Bone Health and Osteoporosis Center
Cincinnati, Ohio, 45219
Mercy Arthritis and Osteoporosis Center
Des Moines, Iowa, 50322
United Osteoporosis Center
Gainesville, Georgia, 30501
Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, 21740
Colorado Center for Bone Research
Lakewood, Colorado, 80227
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502
Oregon Health Sciences University
Portland, Oregon, 97239
McGuire VA Medical Center
Richmond, Virginia, 23249
Radiant Research
Stuart, Florida, 34996
Catalina Pointe Clinical Research Inc.
Tucson, Arizona, 85704
Diablo Clinical Research
Walnut Creek, California, 94598
Helen Hayes Hospital
West Haverstraw, New York, 10993
Radiant Research
Wyomissing, Pennsylvania, 19610
Canada7 sites
QEII HealthSciences Center
Halifax, Nova Scotia, B3H 2Y9
Charlton Medical Building
Hamilton, Ontario, L8N 1Y2
Centre De Recherche Clinique De Laval
Laval, Quebec, H7T 2P5
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Groupe de Recherche en Rhumatologie et Maladies Osseuses
Sainte-Foy, Quebec, G1V 3M7
Saskatoon Osteoporosis Center
Saskatoon, Saskatchewan, S7K 0H6
Clinical Research Center
Vancouver, British Columbia, V5Z 2N6
Australia3 sites
Repatriation General Hospital
Daw Park, South Australia, 5041
Keogh Institute for Medical Research
Nedlands, Western Australia, 6009
Garvan Institute of Medical Research
Sydney, New South Wales, 2010
About this study
The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.
- Conditions
- Osteoporosis
- Being tested
- Zoledronic Acid
- Keywords
- Male Osteoporosis
- Medical subject headings
- Osteoporosis
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 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
Secondary outcomes (3)
To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline
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 startApr 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 288 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097825
- Sponsor's protocol ID
- CZOL446M2308
- Status last verified
- Apr 2012
- First submitted
- 30 Nov 2004
- Last updated
- 27 Apr 2012
- Results posted
- No
Publications
Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.
PubMed 21037195
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
- Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
- ClinicalTrials.gov ID
- NCT00097825
- Acronym / sponsor ID
- CZOL446M2308
- Conditions
- Osteoporosis
- Keywords
- Male Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (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 goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male, 25-85 years old
Key exclusion criteria (3 listed)
- Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
- History of severe liver, kidney or eye disease
- 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 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
3 secondary outcomes
To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline
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.
- Derived from this study: PubMed 21037195Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.
- For information regarding US facilities, click this hyperlink.Link provided by the sponsor.
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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.
26 sites in 3 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 26 sites in 3 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 1 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 26 sites in United States, Canada, Australia. 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 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097825, which also lists 1 linked publication.
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.