This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
190
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\*(Year 9 - Year 6)/Year 6.
Time frame: Year 6 (baseline) and Year 9
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\*(Year 9 - Year 6)/Year 6.
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\*(Year 9 - Year 6)/Year 6.
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100\*(Year 9 - Year 0)/Year 0.
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Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Lakewood, Colorado, United States
Novartis Investigative Site
Gainesville, Georgia, United States
Novartis Investigative Site
Indiamapolis, Indiana, United States
Novartis Investigative Site
Bangor, Maine, United States
Novartis Investigative Site
Albuquerque, New Mexico, United States
Novartis Investigative Site
Fargo, North Dakota, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Richmond, Virginia, United States
Novartis Investigative Site
Seattle, Washington, United States
...and 47 more locations
Time frame: Year 0 (core baseline), Year 7, Year 8, Year 9
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100\*(Year 9 - Year 0)/Year 0.
Time frame: Year 0 (core baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6
Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.
Time frame: Year 6 (extension 2 baseline), Year 9 (3 years of study duration)
Mean of Time to First Clinical Fracture
The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
Time frame: over 3 years of study duration
Change in Height at Years 7, 8 and 9 Relative to Year 6
Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.
Time frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9