Phase 3
Completed N=190
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
Post-menopausal Osteoporosis
Source: ClinicalTrials.gov NCT00718861 ↗
Enrolled (actual)
190
Serious AEs
27.8%
Results posted
Dec 2013
Primary outcomePrimary: Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9 — -0.54; -1.31 Percentage Change of BMD
Summary
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9 |
-0.54; -1.31 | — |
| SECONDARY Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6 |
-0.28; -0.83; -0.14; -1.06 | — |
| SECONDARY Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6 |
-0.78; -1.24; 0.00; -0.88; -1.11; -1.17 | — |
| SECONDARY Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 |
4.81; 3.73; 5.35; 3.65; 4.64; 3.68 | — |
| SECONDARY Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 |
5.11; 3.86; 6.12; 4.43; 4.16; 3.88 | — |
| SECONDARY Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 |
0.19; 0.18; 0.2; 0.22; 0.22; 0.2 | — |
| SECONDARY Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 |
25.89; 24.98; 25.69; 27.79; 26.07; 25.19 | — |
| SECONDARY Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 |
8.16; 8.95; 8.4; 10.00; 7.84; 9.57 | — |
| SECONDARY Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6 |
3; 5; 3; 5 | — |
| SECONDARY Mean of Time to First Clinical Fracture |
1212.05; 1204.65 | — |
| SECONDARY Change in Height at Years 7, 8 and 9 Relative to Year 6 |
-5.29; -4.84; -10.16; -9.90; -13.31; -11.65 | — |
Eligibility Criteria
Inclusion Criteria
- Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00718861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.