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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718861
First received: July 18, 2008
Last updated: August 19, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 137
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

Ages Eligible for Study:   65 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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Fargo, North Dakota, United States, 58103
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
United States, Virginia
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Richmond, Virginia, United States, 23249
United States, Washington
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Seattle, Washington, United States, 98144
Argentina
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Caba, Buenos Aires, Argentina, C1221ADC
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Quilmes, Buenos Aires, Argentina, B1878DVB
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Buenos Aires, Argentina, C1117ABH
Australia, New South Wales
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St. Leonards, New South Wales, Australia, 2065
Australia, Victoria
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Geelong, Victoria, Australia, 3220
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Parkville, Victoria, Australia, 3052
Belgium
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 2K4
Canada, Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Sainte-Foy, Quebec, Canada, G1v 3M7
Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Medellín, Colombia
Finland
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Helsinki, Finland, 00100
France
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Lyon, France, 69003
Germany
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Berlin, Germany, 12200
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Braunfels, Germany, 35619
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Hannover, Germany, 30167
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Magdeburg, Germany, 39110
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Muenchen, Germany, 80809
Hong Kong
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Hong Kong, Hong Kong
Hungary
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Balatonfured, Hungary, 8230
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Budapest, Hungary, 1023
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Budapest, Hungary, 1083
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Budapest, Hungary, 1085
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Debrecen, Hungary, 4012
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Gyor, Hungary, 9023
Italy
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Arenzano, GE, Italy, 16011
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Padova, PD, Italy, 35128
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Siena, SI, Italy, 53100
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Valeggio Sul Mincio, VR, Italy, 37067
New Zealand
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Grafton, Auckland, New Zealand
Norway
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Bergen, Norway, 5094
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Hamar, Norway, 2317
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Oslo, Norway, 0050
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Oslo, Norway, 0176
Poland
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Bialystok, Poland, 15-337
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Warsaw, Poland, 04-730
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Warszawa, Poland, 02-341
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Warszawa, Poland, 00-416
Sweden
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Goteborg, Sweden, 413 45
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Stockholm, Sweden, SE-171 76
Switzerland
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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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00718861     History of Changes
Other Study ID Numbers: CZOL446H2301E2, 2007-005383-27
Study First Received: July 18, 2008
Results First Received: November 8, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Ministry of Health
Canada: Canadian Institutes of Health Research
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Switzerland: Swissmedic
Thailand: Ministry of Public Health

Keywords provided by Novartis:
Osteoporosis
zoledronic acid
post-menopausal

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

ClinicalTrials.gov processed this record on September 18, 2014