3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

October 2, 2014 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1117ABH
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1221ADC
        • Novartis Investigative Site
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Novartis Investigative Site
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3052
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2K4
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Novartis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1v 3M7
        • Novartis Investigative Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigative Site
      • Bogotá, Colombia
        • Novartis Investigative Site
      • Medellín, Colombia
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00100
        • Novartis Investigative Site
  • France
      • Lyon, France, 69003
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 12200
        • Novartis Investigative Site
      • Braunfels, Germany, 35619
        • Novartis Investigative Site
      • Hannover, Germany, 30167
        • Novartis Investigative Site
      • Magdeburg, Germany, 39110
        • Novartis Investigative Site
      • Muenchen, Germany, 80809
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Balatonfured, Hungary, 8230
        • Novartis Investigative Site
      • Budapest, Hungary, 1083
        • Novartis Investigative Site
      • Budapest, Hungary, 1023
        • Novartis Investigative Site
      • Budapest, Hungary, 1085
        • Novartis Investigative Site
      • Debrecen, Hungary, 4012
        • Novartis Investigative Site
      • Gyor, Hungary, 9023
        • Novartis Investigative Site
  • Italy
    • GE
      • Arenzano, GE, Italy, 16011
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
    • VR
      • Valeggio Sul Mincio, VR, Italy, 37067
        • Novartis Investigative Site
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, 5094
        • Novartis Investigative Site
      • Hamar, Norway, 2317
        • Novartis Investigative Site
      • Oslo, Norway, 0050
        • Novartis Investigative Site
      • Oslo, Norway, 0176
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-337
        • Novartis Investigative Site
      • Warsaw, Poland, 04-730
        • Novartis Investigative Site
      • Warszawa, Poland, 02-341
        • Novartis Investigative Site
      • Warszawa, Poland, 00-416
        • Novartis Investigative Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Novartis Investigative Site
      • Stockholm, Sweden, SE-171 76
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8091
        • Novartis Investigative Site
  • Thailand
      • Chaingmai, Thailand, 50200
        • Novartis Investigative Site
      • Khonkaen, Thailand, 40002
        • Novartis Investigative Site
  • United States
    • California
      • San Diego, California, United States, 92103-6204
        • Novartis Investigative Site
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Novartis Investigative Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Novartis Investigative Site
    • Indiana
      • Indiamapolis, Indiana, United States, 46202
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novartis Investigative Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Novartis Investigative Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98144
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching placebo administered intravenously.
Drug: Placebo
Experimental: Zoledronic acid
Drug: Zoledronic acid
Other Names:
  • Reclast®, Aclasta®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Year 6 (baseline) and Year 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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
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
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.
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
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.
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)
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.
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
The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
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
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.
Year 6 (extension 2 baseline), Year 7, Year 8, Year 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CZOL446H2301E2
  • 2007-005383-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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