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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,456
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.
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).
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)
Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP
The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.
Time frame: Year 4.5
Bone Resorption and Formation Biochemical Markers at Year 6: P1NP
The amount of serum P1NP as determined by the central laboratory
Time frame: Year 6
Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 \* (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
Time frame: 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
The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 \* (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
Time frame: 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
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Southern Arizona VA
Tucson, Arizona, United States
University of Arkansas for Medical Science
Little Rock, Arkansas, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Osteoporosis Prevention Center
San Diego, California, United States
Diablo Clinical Research, Inc
Walnut Creek, California, United States
Colorado Center for Bone Research
Lakewood, Colorado, United States
CRIA Research
Fort Lauderdale, Florida, United States
Radiant Research
Stuart, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
United Osteoporosis Centers (UOC)
Gainesville, Georgia, United States
...and 21 more locations
The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 \* (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
Time frame: 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 Distal Radius at Year 6 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 \* (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3
The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 \* (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
Time frame: 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 Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3
The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 \* (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)
Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures
Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.
Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6
Number of Participants With Incidence of Clinical Fracture
Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.
Time frame: Extension Baseline (Year 3; Month 36) to Year 6
Qualitative Bone Biopsy Parameters
Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).
Time frame: End of Study Visit at Year 6
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion
Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion
Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion
Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion
Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion
The Number of Participants With Clinically Significant Laboratory Parameters
Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.
Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6