Clinical trial NCT00145327: Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Osteoporosis, Zoledronic Acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 2456
Sex: FEMALE
Minimum age (years): 68
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3
timeFrame: 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:
measure: Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP
timeFrame: Year 4.5
measure: Bone Resorption and Formation Biochemical Markers at Year 6: P1NP
timeFrame: Year 6
measure: Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
measure: Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
measure: Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
measure: Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
measure: Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)
measure: Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
measure: Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures
timeFrame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
measure: Number of Participants With Incidence of Clinical Fracture
timeFrame: Extension Baseline (Year 3; Month 36) to Year 6
measure: Qualitative Bone Biopsy Parameters
timeFrame: End of Study Visit at Year 6
measure: Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion
timeFrame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion
measure: Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion
timeFrame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion
measure: Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion
timeFrame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion
measure: The Number of Participants With Clinically Significant Laboratory Parameters
timeFrame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: San Diego
country: United States
facility: Osteoporosis Prevention Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc
state: California
city: Lakewood
country: United States
facility: Colorado Center for Bone Research
state: Colorado
city: Ft. Lauderdale
country: United States
facility: CRIA Research
state: Florida
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Gainesville
country: United States
facility: United Osteoporosis Centers (UOC)
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Center for Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: School of Medicine
state: Indiana
city: Munster
country: United States
facility: Medical Specialist Clinical Research Center
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bangor
country: United States
facility: Maine Center for Osteoporosis Research and Education
state: Maine
city: Hagerstown
country: United States
facility: Osteoporosis Clinical Trial Center
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Groups
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University Center for Clinical Studies
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center Inc
state: New Mexico
city: Mineola
country: United States
facility: Winthrop U Hospital
state: New York
city: Fargo
country: United States
facility: Odyssey Research Services/CCRC Internal Medical
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Bone Health and Osteoporosis Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Wyomissing
country: United States
facility: Radiant Research
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Endocrinology Clinical Research Unit
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee Health Science
state: Tennessee
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Richmond
country: United States
facility: VA Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Puget Sound Osteoporosis Center
state: Washington
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.
citation: Black 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.