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Double-Blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis) - Article


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Gamma-Linolenic Acid

GLA


Clinical Trial: Double-Blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

This study is currently recruiting patients.
Verified by Novartis September 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00145327

Purpose

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 study (HORIZON Pivotal Fracture Trial).
Condition Intervention Phase
Osteoporosis
 Drug: Zoledronic Acid
Phase III

MedlinePlus related topics:  Osteoporosis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: June 2005

Eligibility

Ages Eligible for Study:  65 Years   -   93 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

  • Poor kidney, eye, or liver health
  • Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
  • Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145327

Novartis Pharmaceuticals      862-778-8300 

Arizona
      Southern Arizona VA, Tucson,  Arizona,  85723,  United States; Not yet recruiting
Lynda Seal  520-629-4732  Ext. 5059 

Arkansas
      University of Arkansas for Medical Science, Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
Beverly Tolliver  501-686-5087 

California
      Osteoporosis Prevention Center, San Diego,  California,  92103,  United States; Recruiting
Karen McCrea, RT  619-291-2321 

      University of California Davis- Gen Medical Research, Sacramento,  California,  95817,  United States; Not yet recruiting
Ann Koscki  916-734-3219 

      Osteoporosis Medical Center, Beverly Hills,  California,  90211,  United States; Not yet recruiting
Carol Joseph, RN  310-358-8350 

      Diablo Clinical Research, Inc, Walnut Creek,  California,  94598,  United States; Not yet recruiting
Colleen Kirkland  925-930-7267  Ext. 224 

Colorado
      Colorado Center for Bone Research, Lakewood,  Colorado,  80227,  United States; Not yet recruiting
Carol Wasnok, RN  303-980-9985 

Florida
      Comprehensive Clinical Trials, LLC, West Palm Beach,  Florida,  33409,  United States; Not yet recruiting
Linda Wyatt  561-478-3177 

      Radiant Research, Stuart,  Florida,  34996,  United States; Recruiting
Diane Anderson  772-781-3000  Ext. 221 

      CRIA Research, Ft. Lauderdale,  Florida,  33334,  United States; Not yet recruiting
Janet Fitzpatrick  954-229-0425 

Georgia
      United Osteoporosis Centers (UOC), Gainesville,  Georgia,  30501,  United States; Recruiting
Lynn Henson  770-534-5154 

Illinois
      Northwestern University Center for Clinical Research, Chicago,  Illinois,  60611,  United States; Not yet recruiting
Lucius Robinson  312-503-2312 

Indiana
      School of Medicine, Indianapolis,  Indiana,  46202,  United States; Not yet recruiting
Connie Sullivan  317-274-8431 

Kansas
      Heartland Research Associates, LLC, Wichita,  Kansas,  67207,  United States; Recruiting
Terri Ford  316-689-6634 

Maine
      Maine Center for Osteoporosis Research and Education, Bangor,  Maine,  04401,  United States; Recruiting
Deb Storm  207-262-1176 

Maryland
      Osteoporosis Clinical Trial Center, Hagerstown,  Maryland,  21740,  United States; Recruiting
Kathleen Renee, RN  301-791-6680 

Massachusetts
      Clinical Pharmacology Study Groups, Worcester,  Massachusetts,  01610,  United States; Recruiting
Mary Coughlin RN  508-752-1824 

Missouri
      Washington University Center for Clinical Studies, St. Louis,  Missouri,  62110,  United States; Not yet recruiting
Sherry Banez-Muth, RN  314-454-8023 

New Mexico
      New Mexico Clinical Research and Osteoporosis Center Inc, Albuquerque,  New Mexico,  87106,  United States; Recruiting
Valerie White  505-855-5505 

New York
      Winthrop U Hospital, Mineola,  New York,  11501,  United States; Not yet recruiting
Jane S Moore RN/BSN, CCRC  516-663-4776 

North Dakota
      Odyssey Research Services/CCRC Internal Medical, Fargo,  North Dakota,  58104,  United States; Recruiting
Deb Pilon  701-232-7705 

Ohio
      University of Cincinnati Bone Health and Osteoporosis Center, Cincinnati,  Ohio,  45219,  United States; Not yet recruiting
Cindy Powell  513-475-7400  Ext. 7418 

Pennsylvania
      Thomas Jefferson University Hospital, Philadelphia,  Pennsylvania,  19131,  United States; Not yet recruiting
Elizabeth Grace  215-578-3433 

      Radiant Research, Wyomissing,  Pennsylvania,  19610,  United States; Recruiting
Ellie Alderfer  610-374-8291  Ext. 237 

      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15261,  United States; Not yet recruiting
Linda Prebehalla  412-383-2428 

Rhode Island
      Rhode Island Hospital, Endocrinology Clinical Research Unit, Providence,  Rhode Island,  02903,  United States; Not yet recruiting
Kim Conklin  401-444-2091 

Tennessee
      University of Tennessee Health Science, Memphis,  Tennessee,  38105,  United States; Not yet recruiting
Page Igou, CCRC  901-347-8411 

Virginia
      VA Commonwealth University, Richmond,  Virginia,  23298,  United States; Not yet recruiting
Marian Sheppard BSN, CCRC  804-828-8932 

Washington
      Puget Sound Osteoporosis Center, Seattle,  Washington,  98144,  United States; Not yet recruiting
Judy Lore  206-621-4389 

More Information

Study ID Numbers:  CZOL446H2301E1
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145327
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


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September 8, 2008



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