Clinical trial NCT00718861: 3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-menopausal Osteoporosis
Keywords: Osteoporosis
zoledronic acid
post-menopausal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 190
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
timeFrame: Year 6 (baseline) and Year 9
Secondary outcomes:
measure: Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6
timeFrame: Year 6 (extension 2 baseline), Year 7, Year 8
measure: Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6
timeFrame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
measure: Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
timeFrame: Year 0 (core baseline), Year 7, Year 8, Year 9
measure: Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
timeFrame: Year 0 (core baseline), Year 7, Year 8, Year 9
measure: Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
timeFrame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
measure: Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
timeFrame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
measure: Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
timeFrame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
measure: Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6
timeFrame: Year 6 (extension 2 baseline), Year 9 (3 years of study duration)
measure: Mean of Time to First Clinical Fracture
timeFrame: over 3 years of study duration
measure: Change in Height at Years 7, 8 and 9 Relative to Year 6
timeFrame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Lakewood
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Indiamapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Bangor
country: United States
facility: Novartis Investigative Site
state: Maine
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: St. Leonards
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Geelong
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Medellín
country: Colombia
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Braunfels
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Balatonfured
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Arenzano
country: Italy
facility: Novartis Investigative Site
state: GE
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Valeggio Sul Mincio
country: Italy
facility: Novartis Investigative Site
state: VR
city: Grafton
country: New Zealand
facility: Novartis Investigative Site
state: Auckland
city: Bergen
country: Norway
facility: Novartis Investigative Site
city: Hamar
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Chaingmai
country: Thailand
facility: Novartis Investigative Site
city: Khonkaen
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: