Phase 3
Completed N=2,456
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Source: ClinicalTrials.gov NCT00145327 ↗Enrolled (actual)
2,456
Serious AEs
26.8%
Results posted
Apr 2011
Primary outcomePrimary: Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 — 0.557; -0.493; 3.337 Percentage Change in BMD
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 |
0.557; -0.493; 3.337 | — |
| SECONDARY Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP |
18.842; 29.677; 17.256 | — |
| SECONDARY Bone Resorption and Formation Biochemical Markers at Year 6: P1NP |
27.356; 30.344; 25.926 | — |
| SECONDARY Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3 |
2.618; 1.196; 6.551 | — |
| SECONDARY Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3 |
3.473; 1.606; 8.875 | — |
| SECONDARY Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3 |
0.378; -0.924; 0.386 | — |
| SECONDARY Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3 |
0.178; -0.567; 0.299 | — |
| SECONDARY Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3 |
0.738; 0.210; 2.697; 0.479; -0.070; 3.228 | — |
| SECONDARY Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3 |
0.577; -0.493; 3.337; 0.083; -1.151; 3.815 | — |
| SECONDARY Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures |
3.0; 6.2; 2.9; 3.4; 7.0; 3.1 | — |
| SECONDARY Number of Participants With Incidence of Clinical Fracture |
51; 51; 91; 7; 4; 7 | — |
| SECONDARY Qualitative Bone Biopsy Parameters |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion |
1.96; 1.28; 0.21 | — |
| SECONDARY Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion |
3.35; 2.23; 2.47 | — |
| SECONDARY Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion |
3.46; 0.71; 1.04 | — |
| SECONDARY The Number of Participants With Clinically Significant Laboratory Parameters |
1; 0; 1; 3; 0; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00145327). 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.