Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis

Condition(s) targeted: Osteoporosis

Intervention: Zoledronic acid 5 mg solution (Drug); Alendronate 70 mg tablets (Drug); Calcium/Vitamin D (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma GmbH, Germany +49 911 273-0, Study Director, Affiliation: Novartis

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.

Official title: A Multi-center, Randomized, Open-label, Controlled, One-year Trial to Measure the Effect of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteopenia and Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12

Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12

Number of Patients With a Clinical Fracture From Baseline to Month 12

Change in Body Height From Baseline to Month 12

Therapy Preference at End of Study (Month 12)

Minimum age: 55 Years. Maximum age: 90 Years. Gender(s): Female.

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.

For site information contact Novartis Pharmaceuticals, Multiple Cities, Germany

Starting date: October 2006
Last updated: June 6, 2011