OsteoporosisPhase 3NCT00145327
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
A Phase 3 study testing Zoledronic Acid in people with Osteoporosis, run by Novartis at 31 sites in 2 countries.
Trial summary
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3. Read more about this study
- Who is it for?
- Ages 68 to 90 years, women only
- Conditions the study is for
- 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
- 2,456 participants
- Where
- 31 sitesin 2 countries
- Study dates
- May 2005to Nov 2009
- 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 68 to 90 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.
Who cannot join
- Poor kidney, eye, or liver health
- Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
- Abnormal calcium levels in the blood
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
New Mexico Clinical Research and Osteoporosis Center Inc
Albuquerque, New Mexico, 87106
Maine Center for Osteoporosis Research and Education
Bangor, Maine, 04401
Osteoporosis Medical Center
Beverly Hills, California, 90211
Northwestern University Center for Clinical Research
Chicago, Illinois, 60611
University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati, Ohio, 45219
Odyssey Research Services/CCRC Internal Medical
Fargo, North Dakota, 58104
CRIA Research
Fort Lauderdale, Florida, 33334
United Osteoporosis Centers (UOC)
Gainesville, Georgia, 30501
Osteoporosis Clinical Trial Center
Hagerstown, Maryland, 21740
School of Medicine
Indianapolis, Indiana, 46202
Colorado Center for Bone Research
Lakewood, Colorado, 80227
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
University of Tennessee Health Science
Memphis, Tennessee, 38105
Winthrop U Hospital
Mineola, New York, 11501
Medical Specialist Clinical Research Center
Munster, Indiana, 46321
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19131
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Rhode Island Hospital, Endocrinology Clinical Research Unit
Providence, Rhode Island, 02903
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
VA Commonwealth University
Richmond, Virginia, 23298
Osteoporosis Prevention Center
San Diego, California, 92103
Puget Sound Osteoporosis Center
Seattle, Washington, 98144
Washington University Center for Clinical Studies
St Louis, Missouri, 62110
Radiant Research
Stuart, Florida, 34996
Southern Arizona VA
Tucson, Arizona, 85723
Diablo Clinical Research, Inc
Walnut Creek, California, 94598
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Clinical Pharmacology Study Groups
Worcester, Massachusetts, 01610
Radiant Research
Wyomissing, Pennsylvania, 19610
About this study
Official title: A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.
- Conditions
- Osteoporosis
- Being tested
- Zoledronic Acid, Placebo
- Keywords
- Osteoporosis, Zoledronic Acid
- 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
Also called Reclast, Aclasta
Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
PlaceboDrug
Also called Reclast, Aclasta
100 mL physiologic 0.9% normal saline for intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid 6 | Experimental | Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment. Receives: Drug: Zoledronic Acid |
| Zoledronic Acid 3 Placebo 3 | Placebo comparator | Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study. Receives: Drug: Placebo |
| Placebo 3 Zoledronic Acid 3 | Experimental | Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study. Receives: Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3
The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)
Secondary outcomes (15)
Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP
The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.
Measured: Year 4.5
Bone Resorption and Formation Biochemical Markers at Year 6: P1NP
The amount of serum P1NP as determined by the central laboratory
Measured: Year 6
Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3
The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures
Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.
Measured: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
Number of Participants With Incidence of Clinical Fracture
Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.
Measured: Extension Baseline (Year 3; Month 36) to Year 6
Qualitative Bone Biopsy Parameters
Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).
Measured: End of Study Visit at Year 6
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion
Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.
Measured: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion
Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.
Measured: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion
Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.
Measured: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion
The Number of Participants With Clinically Significant Laboratory Parameters
Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.
Measured: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6
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 startMay 2005
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145327
- Sponsor's protocol ID
- CZOL446H2301E1
- Status last verified
- Jun 2011
- First submitted
- 1 Sep 2005
- Last updated
- 28 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Eastell R, Boonen S, Cosman F, Reid IR, Palermo L, Cummings SR, Black DM. Relationship between pretreatment rate of bone loss and bone density response to once-yearly ZOL: HORIZON-PFT extension study. J Bone Miner Res. 2015 Mar;30(3):570-4. doi: 10.1002/jbmr.2361.
PubMed 25214069Black DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, Cummings SR, Hue TF, Lippuner K, Lakatos P, Leung PC, Man Z, Martinez RL, Tan M, Ruzycky ME, Su G, Eastell R. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012 Feb;27(2):243-54. doi: 10.1002/jbmr.1494.
PubMed 22161728
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
- ClinicalTrials.gov ID
- NCT00145327
- Acronym / sponsor ID
- CZOL446H2301E1
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Zoledronic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,456 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid 6 | Experimental | Drug: Zoledronic AcidPatients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment. |
| Zoledronic Acid 3 Placebo 3 | Placebo comparator | Drug: PlaceboPatients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study. |
| Placebo 3 Zoledronic Acid 3 | Experimental | Drug: Zoledronic AcidPatients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study. |
Who may qualify
- Ages
- 68 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.
Key exclusion criteria (4 listed)
- Poor kidney, eye, or liver health
- Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
- Abnormal calcium levels in the blood
- 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 AcidAlso: Reclast, AclastaZoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion. | Drug | Placebo 3 Zoledronic Acid 3, Zoledronic Acid 6 |
| PlaceboAlso: Reclast, Aclasta100 mL physiologic 0.9% normal saline for intravenous infusion. | Drug | Zoledronic Acid 3 Placebo 3 |
Primary outcome
Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)
The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).
15 secondary outcomes
Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP
Time frame: Year 4.5
Bone Resorption and Formation Biochemical Markers at Year 6: P1NP
Time frame: Year 6
Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
Number of Participants With Incidence of Clinical Fracture
Time frame: Extension Baseline (Year 3; Month 36) to Year 6
Qualitative Bone Biopsy Parameters
Time frame: End of Study Visit at Year 6
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion
The Number of Participants With Clinically Significant Laboratory Parameters
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25214069Eastell R, Boonen S, Cosman F, Reid IR, Palermo L, Cummings SR, Black DM. Relationship between pretreatment rate of bone loss and bone density response to once-yearly ZOL: HORIZON-PFT extension study. J Bone Miner Res. 2015 Mar;30(3):570-4. doi: 10.1002/jbmr.2361.
- Derived from this study: PubMed 22161728Black DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, Cummings SR, Hue TF, Lippuner K, Lakatos P, Leung PC, Man Z, Martinez RL, Tan M, Ruzycky ME, Su G, Eastell R. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012 Feb;27(2):243-54. doi: 10.1002/jbmr.1494.
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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 chair
Sponsor GmbH
31 sites in 2 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 at 31 sites in 2 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Germany. 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 20 Apr 2011). 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 Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 (time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)). 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 NCT00145327, which also lists 2 linked publications.
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 28 Jun 2011.