Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
1 other identifier
interventional
2,456
2 countries
31
Brief Summary
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 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2005
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
April 20, 2011
CompletedJune 28, 2011
June 1, 2011
4.5 years
September 1, 2005
January 21, 2011
June 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3
The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 \*(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).
Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)
Secondary Outcomes (15)
Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP
Year 4.5
Bone Resorption and Formation Biochemical Markers at Year 6: P1NP
Year 6
Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3
Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3
Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3
Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
- +10 more secondary outcomes
Study Arms (3)
Zoledronic Acid 6
EXPERIMENTALPatients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
Zoledronic Acid 3 Placebo 3
PLACEBO COMPARATORPatients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
Placebo 3 Zoledronic Acid 3
EXPERIMENTALPatients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
Interventions
Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
100 mL physiologic 0.9% normal saline for intravenous infusion.
Eligibility Criteria
You may qualify if:
- Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (31)
Southern Arizona VA
Tucson, Arizona, 85723, United States
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205, United States
Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
Osteoporosis Prevention Center
San Diego, California, 92103, United States
Diablo Clinical Research, Inc
Walnut Creek, California, 94598, United States
Colorado Center for Bone Research
Lakewood, Colorado, 80227, United States
CRIA Research
Fort Lauderdale, Florida, 33334, United States
Radiant Research
Stuart, Florida, 34996, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, 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
Medical Specialist Clinical Research Center
Munster, Indiana, 46321, 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
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Radiant Research
Wyomissing, Pennsylvania, 19610, 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
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249, United States
VA Commonwealth University
Richmond, Virginia, 23298, United States
Puget Sound Osteoporosis Center
Seattle, Washington, 98144, United States
Novartis
Nuremberg, Germany
Related Publications (2)
Eastell R, Boonen S, Cosman F, Reid IR, Palermo L, Cummings SR, Black DM. Relationship between pretreatment rate of bone loss and bone density response to once-yearly ZOL: HORIZON-PFT extension study. J Bone Miner Res. 2015 Mar;30(3):570-4. doi: 10.1002/jbmr.2361.
PMID: 25214069DERIVEDBlack DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, Cummings SR, Hue TF, Lippuner K, Lakatos P, Leung PC, Man Z, Martinez RL, Tan M, Ruzycky ME, Su G, Eastell R. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012 Feb;27(2):243-54. doi: 10.1002/jbmr.1494.
PMID: 22161728DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Sponsor GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
May 1, 2005
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
June 28, 2011
Results First Posted
April 20, 2011
Record last verified: 2011-06