Phase 3
N=604
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00404820 ↗Enrolled (actual)
604
Serious AEs
10.6%
Results posted
Jul 2011
Primary outcome: 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 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic acid 5 mg solution (Drug); Alendronate 70 mg tablets (Drug); Calcium/Vitamin D (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Novartis
- Primary completion
- Dec 2008
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 | — |
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.
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.