Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism 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”

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.

Intervention(s) in this Clinical Trial

• Drug: Zoledronic acid 5 mg solution
  • Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.
• Drug: Alendronate 70 mg tablets
  • Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.
• Drug: Calcium/Vitamin D
  • Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zoledronic acid 5 mg
  • Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
• Active Comparator: Alendronate 70 mg
  • Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

Primary Measures

• 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
  • Time Frame: Screening to end of study (Month 12)
    Safety Issue?: No
• 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
  • Time Frame: Screening to end of study (Month 12)
    Safety Issue?: No

Secondary Measures

• Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12
  • Time Frame: Screening to end of study (Month 12)
    Safety Issue?: No
• Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12
  • Time Frame: Baseline to end of study (Month 12)
    Safety Issue?: No
• Number of Patients With a Clinical Fracture From Baseline to Month 12
  • Time Frame: Baseline to end of study (Month 12)
    Safety Issue?: No
• Change in Body Height From Baseline to Month 12
  • Time Frame: Baseline to end of study (Month 12)
    Safety Issue?: No
• Therapy Preference at End of Study (Month 12)
  • Time Frame: Month 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharma GmbH, Germany +49 911 273-0 Study Director Novartis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404820

Study ID Number: CZOL446HDE31

ClinicalTrials.gov Identifier: NCT00404820

Health Authority: Germany: Federal Institute for Drugs and Medical Devices