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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00718861
First Posted: July 21, 2008
Last Update Posted: October 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Condition Intervention Phase
Post-menopausal Osteoporosis Drug: Placebo Drug: Zoledronic acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 190
Study Start Date: May 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo administered intravenously.
Drug: Placebo
Experimental: Zoledronic acid Drug: Zoledronic acid
Other Name: Reclast®, Aclasta®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718861


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00718861     History of Changes
Other Study ID Numbers: CZOL446H2301E2
2007-005383-27 ( EudraCT Number )
First Submitted: July 18, 2008
First Posted: July 21, 2008
Results First Submitted: November 8, 2013
Results First Posted: December 30, 2013
Last Update Posted: October 9, 2014
Last Verified: September 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Osteoporosis
zoledronic acid
post-menopausal

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs