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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

May 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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