3-Year Efficacy and Safety Study of Zoledronic Acid in Post-Menopausal Women With Osteoporosis Treated With Zoledronic Acid for 6 Years

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Trial phase: 
Phase III
Recruitment status: 
Enrolling by invitation

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Background information
Trial ID: 
NCT00718861
Other unique IDs: 
CZOL446H2301E2
Official title: 

A 3-Year, Multicenter, Double-Blind, Randomized, Placebo-Controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

Detailed description: 

 

Number to be enrolled: 
400 patients
Clinical information
Age groups: 
Senior
Gender: 
Female
Eligibility criteria: 

Inclusion Criteria:

  • Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

  • Poor kidney, eye, liver health
  • Use of certain therapies for osteoporosis in study CZOL446H2301E1
  • Abnormal calcium levels

Other protocol-defined inclusion/exclusion criteria may apply

Study design: 
Treatment
Randomized
Safety/Efficacy Study
Placebo Control
Parallel Assignment
Interventions: 
Placebo
zoledronic acid
Conditions treated: 
Post-Menopausal Osteoporosis
Outcome measurements: 

Differences between treatment groups in the percentage change of total hip and femoral neck BMD (bone mineral density) at year 7, 8 and 9 compared to year 0

Differences between treatment groups in the percentage change of total hip BMD at year 7 and 8 compared to year 6

Relative change in biomarkers

Relative change in height

Differences between treatment groups in the number of clinical fractures

Funding
Funding types: 
INDUSTRY
Sponsor: 
Novartis
Dates
Date the data was first received: 
Fri, 2008-07-18
Trial start date: 
Tue, 2008-07-01
Trial completion date: 
Wed, 1969-12-31
Trial last updated: 
Fri, 2008-07-18