Phase 3
Completed N=604
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT00404820 ↗Enrolled (actual)
604
Serious AEs
10.6%
Results posted
Jul 2011
Primary outcomePrimary: Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population — 0.282; 0.270 ng/ml
Summary
The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population |
0.282; 0.270 | — |
| PRIMARY Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population |
0.293; 0.294 | — |
| SECONDARY Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 |
28.2; 25.5 | — |
| SECONDARY Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12 |
-1.2; -0.6 | — |
| SECONDARY Number of Patients With a Clinical Fracture From Baseline to Month 12 |
10; 4 | — |
| SECONDARY Change in Body Height From Baseline to Month 12 |
-0.1; 0.0 | — |
| SECONDARY Therapy Preference at End of Study (Month 12) |
30; 16; 330; 82; 48; 93 | — |
Eligibility Criteria
Inclusion Criteria
- Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women
Exclusion Criteria
- Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00404820). 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.