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A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate - Article


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Valproic Acid Oral Syrup

Depakene Oral Syrup; Valproate Sodium Syrup


Clinical Trial: A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

This study is no longer recruiting patients.

Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals

Purpose

The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.

Condition Treatment or Intervention Phase
Osteoporosis
 Drug: zoledronic acid
Phase III

MedlinePlus related topics:  Osteoporosis

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

Further Study Details: 
Primary Outcomes: Bone markers

Study start: June 2004

Eligibility

Ages Eligible for Study:  45 Years   -   79 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

  • Postmenopausal women between 45 and 79 years of age
  • Must be osteopenic/osteoporotic

Exclusion Criteria:

  • Any women of child-bearing potential

Location Information


Alabama
      Univ. of Alabama/Division of Clinical Immunology and Rheumatology, Birmingham,  Alabama,  35294,  United States

California
      Radiant Research, San Diego,  California,  92108,  United States

Colorado
      Denver Arthritis Clinic, Denver,  Colorado,  80230,  United States

Florida
      Florida Medical Research Institute, Gainesville,  Florida,  32605,  United States

Illinois
      Northwestern Center for Clinical Research, Chicago,  Illinois,  60611,  United States

Maryland
      The Center for Rheumatology and Bone Research, Wheaton,  Maryland,  20902,  United States

Michigan
      Midwest Arthritis Center, Kalamazoo,  Michigan,  49048-1634,  United States

Missouri
      St. John's Medical Research, Springfield,  Missouri,  65807,  United States

Montana
      Deaconess Billings Clinic Research Division, Billings,  Montana,  59101,  United States

New Jersey
      UMDNJ-Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States

New York
      Helen Hayes Hospital - Regional Bone Clinic, West Haverstraw,  New York,  10993,  United States

Ohio
      Private Practice, Mayfield Village,  Ohio,  44143,  United States

Tennessee
      The Arthritis Clinic of Jackson, Jackson,  Tennessee,  38305,  United States

Texas
      Radiant Research, Dallas,  Texas,  75235,  United States

      Univ. of North Texas Health Science Center at Fort Worth, Fort Worth,  Texas,  76107,  United States

      St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education, Houston,  Texas,  77030,  United States

Utah
      Women's Health Center, Salt Lake City,  Utah,  84117,  United States

West Virginia
      Valley Medical Associates, Lewisburg,  West Virginia,  24901,  United States

More Information

Study ID Numbers:  CZOL446H2315
Record last reviewed:  December 2004
Last Updated:  January 4, 2005
Record first received:  January 3, 2005
ClinicalTrials.gov Identifier:  NCT00100555
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 7, 2008



Page Updated: June 1, 2005
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