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

Condition(s) targeted: Osteoporosis

Intervention: Zoledronic Acid (Drug); Placebo (Drug); Zoledronic acid (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Sponsor

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).

Official title: A Three Years, Double-Blind Extension to CZOL446H2301 to Evaluate the Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent change in bone mineral density (BMD) of femoral neck at year 6 relative to year 3

Secondary outcome:

Change from baseline of biochemical markers of bone turnover at different time points

Percent change from baseline in BMD of spine and distal radius at year 4.5 and 6

Percent change from baseline in BMD of femoral neck, total hip and trochanter at different time points

Proportion of patients with new vertebral fractures and incidence of clinical fracture

Bone biopsy to evaluate bone quality

Evaluation of safety parameters (renal function, laboratory parameters, AE profile)

Minimum age: 65 Years. Maximum age: 93 Years. Gender(s): 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.

Novartis, Nuernberg, Germany

Southern Arizona VA, Tucson, Arizona 85723, United States

University of Arkansas for Medical Science, Little Rock, Arkansas 72205, United States

Osteoporosis Prevention Center, San Diego, California 92103, United States

Osteoporosis Medical Center, Beverly Hills, California 90211, United States

Diablo Clinical Research, Inc, Walnut Creek, California 94598, United States

Colorado Center for Bone Research, Lakewood, Colorado 80227, United States

Comprehensive Clinical Trials, LLC, West Palm Beach, Florida 33409, United States

Radiant Research, Stuart, Florida 34996, United States

CRIA Research, Ft. Lauderdale, Florida 33334, United States

United Osteoporosis Centers (UOC), Gainesville, Georgia 30501, United States

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

School of Medicine, Indianapolis, Indiana 46202, United States

Heartland Research Associates, LLC, Wichita, Kansas 67207, United States

Maine Center for Osteoporosis Research and Education, Bangor, Maine 04401, United States

Osteoporosis Clinical Trial Center, Hagerstown, Maryland 21740, United States

Clinical Pharmacology Study Groups, Worcester, Massachusetts 01610, United States

Washington University Center for Clinical Studies, St. Louis, Missouri 62110, United States

New Mexico Clinical Research and Osteoporosis Center Inc, Albuquerque, New Mexico 87106, United States

Winthrop U Hospital, Mineola, New York 11501, United States

Odyssey Research Services/CCRC Internal Medical, Fargo, North Dakota 58104, United States

University of Cincinnati Bone Health and Osteoporosis Center, Cincinnati, Ohio 45219, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19131, United States

Radiant Research, Wyomissing, Pennsylvania 19610, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States

Rhode Island Hospital, Endocrinology Clinical Research Unit, Providence, Rhode Island 02903, United States

University of Tennessee Health Science, Memphis, Tennessee 38105, United States

VA Commonwealth University, Richmond, Virginia 23298, United States

McGuire Veterans Affairs Medical Center, Richmond, Virginia 23249, United States

Puget Sound Osteoporosis Center, Seattle, Washington 98144, United States

Starting date: June 2005
Ending date: January 2010
Last updated: December 20, 2007