OsteoporosisPhase 3NCT00100555
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
A Phase 3 study testing zoledronic acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 18 sites in United States.
Trial summary
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis. 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
- 120 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2004to Jun 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
- Postmenopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
Who cannot join
- Any women of child-bearing potential
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Deaconess Billings Clinic Research Division
Billings, Montana, 59101
Univ. of Alabama/Division of Clinical Immunology and Rheumatology
Birmingham, Alabama, 35294
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Radiant Research
Dallas, Texas, 75235
Denver Arthritis Clinic
Denver, Colorado, 80230
Univ. of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107
Florida Medical Research Institute
Gainesville, Florida, 32605
St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education
Houston, Texas, 77030
The Arthritis Clinic of Jackson
Jackson, Tennessee, 38305
Midwest Arthritis Center
Kalamazoo, Michigan, 49048-1634
Valley Medical Associates
Lewisburg, West Virginia, 24901
Private Practice
Mayfield Village, Ohio, 44143
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Women's Health Center
Salt Lake City, Utah, 84117
Radiant Research
San Diego, California, 92108
St. John's Medical Research
Springfield, Missouri, 65807
Helen Hayes Hospital - Regional Bone Clinic
West Haverstraw, New York, 10993
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.
- 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.
Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women
Secondary outcomes (3)
To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women
To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2005
- Study completionJun 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
- 120 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100555
- Sponsor's protocol ID
- CZOL446H2315
- Status last verified
- Apr 2012
- First submitted
- 3 Jan 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
- A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
- ClinicalTrials.gov ID
- NCT00100555
- Acronym / sponsor ID
- CZOL446H2315
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, osteopenia, post-menopausal, zoledronic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 4 Jan 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.
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.
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 (2 listed)
- Postmenopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
Key exclusion criteria (2 listed)
- Any women of child-bearing potential
- 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
Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women
3 secondary outcomes
To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women
To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy
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.
18 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 Osteoporosis, run by Novartis Pharmaceuticals at 18 sites in United States.
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 2 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 18 sites in United States. 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?
Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women. 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; AzTrials last refreshed its copy on 8 Nov 2026.