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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718861
First received: July 18, 2008
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The percentage change in total hip BMD at Year 6 (baseline) and Year 9 [ Time Frame: Year 6 (baseline) and Year 9 ] [ Designated as safety issue: No ]
    BMD measured by DXA (dual energy x-ray absorptiometry).


Secondary Outcome Measures:
  • Differences between treatment groups in the percentage change of total hip and femoral neck BMD (bone mineral density) at year 7, 8 and 9 compared to year 0 [ Time Frame: Year 0 (baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    BMD measured by DXA (dual energy x-ray absorptiometry).

  • Differences between treatment groups in the percentage change of total hip BMD at year 7 and 8 compared to year 6 [ Time Frame: Year 6 (baseline), Year 7, Year 8 ] [ Designated as safety issue: No ]
    BMD measured by DXA (dual energy x-ray absorptiometry).

  • Relative change in biomarkers [ Time Frame: Year 6 (baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Serum samples analyzed for parameters of renal and endocrine function including PTH, TSH, Vitamin D and markers of bone turnover.

  • Relative change in height [ Time Frame: Year 6 (baseline), Year 9 ] [ Designated as safety issue: No ]
    Height will be measured using a stadiometer.

  • Differences between treatment groups in the number of clinical fractures [ Time Frame: Year 6 (baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    An x-ray of a current vertebral fracture will be obtained and compared to baseline study radiograph and be defined by semi-quantitative reading. Other clinical fractrures may be confirmed with x-rays, radiology reports or surgical documentation.


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
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
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
Buenos Aires, Argentina, C1117ABH
Novartis Investigative Site
Buenos Aires, Argentina, C1221ADC
Novartis Investigative Site
Buenos Aires, Argentina, B1878DVB
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, 1085
Novartis Investigative Site
Budapest, Hungary, 1023
Novartis Investigative Site
Budapest, Hungary, 1083
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, 0176
Novartis Investigative Site
Oslo, Norway, 0050
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
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 101953
Novartis Investigative Site
Moscow, Russian Federation, 109240
Novartis Investigative Site
Moscow, Russian Federation, 109044
Novartis Investigative Site
Moscow, Russian Federation, 115522
Novartis Investigative Site
S.-Petersburg, Russian Federation, 194354
Novartis Investigative Site
St-Petersburg, Russian Federation, 199034
Novartis Investigative Site
St-Petersburg, Russian Federation, 190068
Novartis Investigative Site
St. Petersburg, Russian Federation, 194291
Novartis Investigative Site
St. Petersburg, Russian Federation, 197758
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

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
Last Updated: May 13, 2013
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 May 19, 2013