Post-menopausal OsteoporosisPhase 3NCT00718861
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
A Phase 3 study testing Zoledronic acid in people with Post-menopausal Osteoporosis, run by Novartis Pharmaceuticals at 57 sites in 18 countries.
Trial summary
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Post-menopausal Osteoporosis
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 57 sitesin 18 countries
- Study dates
- May 2008to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1
Who cannot join
- Poor kidney, eye, liver health
- Use of certain therapies for osteoporosis in study CZOL446H2301E1
- Abnormal calcium levels
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
57 sites in 18 countries.
57 sites in 18 countries
United States10 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87106
Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigative Site
Fargo, North Dakota, 58103
Novartis Investigative Site
Gainesville, Georgia, 30501
Novartis Investigative Site
Indiamapolis, Indiana, 46202
Novartis Investigative Site
Lakewood, Colorado, 80227
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15261
Novartis Investigative Site
Richmond, Virginia, 23249
Novartis Investigative Site
San Diego, California, 92103-6204
Novartis Investigative Site
Seattle, Washington, 98144
Hungary6 sites
Novartis Investigative Site
Balatonfüred, 8230
Novartis Investigative Site
Budapest, 1023
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1085
Novartis Investigative Site
Debrecen, 4012
Novartis Investigative Site
Győr, 9023
Germany5 sites
Novartis Investigative Site
Berlin, 12200
Novartis Investigative Site
Braunfels, 35619
Novartis Investigative Site
Hanover, 30167
Novartis Investigative Site
Magdeburg, 39110
Novartis Investigative Site
München, 80809
Italy4 sites
Novartis Investigative Site
Arenzano, GE, 16011
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Valeggio sul Mincio, VR, 37067
Norway4 sites
Novartis Investigative Site
Bergen, 5094
Novartis Investigative Site
Hamar, 2317
Novartis Investigative Site
Oslo, 0050
Novartis Investigative Site
Oslo, 0176
Poland4 sites
Novartis Investigative Site
Bialystok, 15-337
Novartis Investigative Site
Warsaw, Poland, 04-730
Novartis Investigative Site
Warsaw, 00-416
Novartis Investigative Site
Warsaw, 02-341
Argentina3 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1117ABH
Novartis Investigative Site
Caba, Buenos Aires, C1221ADC
Novartis Investigative Site
Quilmes, Buenos Aires, B1878DVB
Australia3 sites
Novartis Investigative Site
Geelong, Victoria, 3220
Novartis Investigative Site
Parkville, Victoria, 3052
Novartis Investigative Site
St Leonards, New South Wales, 2065
Canada3 sites
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
Sainte-Foy, Quebec, G1v 3M7
Novartis Investigative Site
Vancouver, British Columbia, V5Z 2K4
Colombia3 sites
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Medellín
Belgium2 sites
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
Sweden2 sites
Novartis Investigative Site
Gothenburg, 413 45
Novartis Investigative Site
Stockholm, SE-171 76
Switzerland2 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Zurich, 8091
Thailand2 sites
Novartis Investigative Site
Chaingmai, 50200
Novartis Investigative Site
Khonkaen, 40002
About this study
Official title: A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
- Conditions
- Post-menopausal Osteoporosis
- Being tested
- Placebo, Zoledronic acid
- Keywords
- Osteoporosis, zoledronic acid, post-menopausal
- 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.
PlaceboDrug
Zoledronic acidDrug
Also called Reclast®, Aclasta®
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo administered intravenously. Receives: Drug: Placebo |
| 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.
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
Measured: Year 6 (baseline) and Year 9
Secondary outcomes (10)
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
Measured: Year 6 (extension 2 baseline), Year 7, Year 8
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
Measured: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.
Measured: Year 0 (core baseline), Year 7, Year 8, Year 9
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.
Measured: Year 0 (core baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone
Measured: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.
Measured: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.
Measured: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6
Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.
Measured: Year 6 (extension 2 baseline), Year 9 (3 years of study duration)
Mean of Time to First Clinical Fracture
The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
Measured: over 3 years of study duration
Change in Height at Years 7, 8 and 9 Relative to Year 6
Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.
Measured: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-menopausal 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 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
- NCT00718861
- Sponsor's protocol ID
- CZOL446H2301E2
- Other IDs
- 2007-005383-27
- Status last verified
- Sep 2014
- First submitted
- 18 Jul 2008
- Last updated
- 9 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00718861
- Acronym / sponsor ID
- CZOL446H2301E2
- Conditions
- Post-menopausal Osteoporosis
- Keywords
- Osteoporosis, zoledronic acid, post-menopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered intravenously. |
| Zoledronic acid | Experimental | Drug: Zoledronic acid |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1
Key exclusion criteria (4 listed)
- Poor kidney, eye, liver health
- Use of certain therapies for osteoporosis in study CZOL446H2301E1
- Abnormal calcium levels
- 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 |
|---|---|---|
| Placebo | Drug | Placebo |
| Zoledronic acidAlso: Reclast®, Aclasta® | Drug | Zoledronic acid |
Primary outcome
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
Time frame: Year 6 (baseline) and Year 9
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
10 secondary outcomes
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
Time frame: Year 0 (core baseline), Year 7, Year 8, Year 9
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
Time frame: Year 0 (core baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6
Time frame: Year 6 (extension 2 baseline), Year 9 (3 years of study duration)
Mean of Time to First Clinical Fracture
Time frame: over 3 years of study duration
Change in Height at Years 7, 8 and 9 Relative to Year 6
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-menopausal Osteoporosis
Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Post Menopausal Osteoporosis
RecruitingPhase 4
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Postmenopausal Osteoporosis, Postmenopausal Osteopenia
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
RecruitingObservational study
Sequential Therapies After Osteoanabolic Treatment
Osteoporosis, Postmenopausal
Not yet recruitingObservational study
A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women
Menopause, Menopausal Hormone Therapy
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
57 sites in 18 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 Post-menopausal Osteoporosis, run by Novartis Pharmaceuticals at 57 sites in 18 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 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 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Hungary, Germany, Italy, Norway and 13 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9 (time frame: Year 6 (baseline) and Year 9). 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 9 Oct 2014.