3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
- Conditions
- Post-menopausal Osteoporosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00718861
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 190
- Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1
- Poor kidney, eye, liver health
- Use of certain therapies for osteoporosis in study CZOL446H2301E1
- Abnormal calcium levels
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo administered intravenously. Zoledronic acid Zoledronic acid -
- Primary Outcome Measures
Name Time Method Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9 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.
- Secondary Outcome Measures
Name Time Method Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 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.
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6 Year 6 (extension 2 baseline), Year 7, Year 8 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.
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 Year 0 (core baseline), Year 7, Year 8, 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 0 = 100\*(Year 9 - Year 0)/Year 0.
Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 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
Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 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.
Mean of Time to First Clinical Fracture over 3 years of study duration The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
Change in Height at Years 7, 8 and 9 Relative to Year 6 Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 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.
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 Year 0 (core baseline), Year 7, Year 8, 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 0 = 100\*(Year 9 - Year 0)/Year 0.
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6 Year 6 (extension 2 baseline), Year 7, Year 8, 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.
Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6 Year 6 (extension 2 baseline), Year 9 (3 years of study duration) 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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇹ðŸ‡Khonkaen, Thailand