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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00718861
Registration number
NCT00718861
Ethics application status
Date submitted
18/07/2008
Date registered
21/07/2008
Date last updated
9/10/2014
Titles & IDs
Public title
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
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Scientific 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
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Secondary ID [1]
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2007-005383-27
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Secondary ID [2]
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CZOL446H2301E2
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post-menopausal Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Reproductive Health and Childbirth
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Zoledronic acid
Placebo Comparator: Placebo - Matching placebo administered intravenously.
Experimental: Zoledronic acid -
Treatment: Drugs: Placebo
Treatment: Drugs: Zoledronic acid
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
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Assessment method [1]
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Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
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Timepoint [1]
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Year 6 (baseline) and Year 9
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Secondary outcome [1]
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Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6
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Assessment method [1]
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Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
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Timepoint [1]
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Year 6 (extension 2 baseline), Year 7, Year 8
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Secondary outcome [2]
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Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6
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Assessment method [2]
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Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
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Timepoint [2]
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Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
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Secondary outcome [3]
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Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
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Assessment method [3]
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Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.
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Timepoint [3]
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Year 0 (core baseline), Year 7, Year 8, Year 9
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Secondary outcome [4]
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Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0
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Assessment method [4]
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Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.
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Timepoint [4]
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Year 0 (core baseline), Year 7, Year 8, Year 9
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Secondary outcome [5]
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Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
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Assessment method [5]
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Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone
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Timepoint [5]
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Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
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Secondary outcome [6]
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Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
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Assessment method [6]
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Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.
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Timepoint [6]
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Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
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Secondary outcome [7]
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Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9
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Assessment method [7]
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Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.
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Timepoint [7]
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Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
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Secondary outcome [8]
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Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6
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Assessment method [8]
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Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.
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Timepoint [8]
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Year 6 (extension 2 baseline), Year 9 (3 years of study duration)
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Secondary outcome [9]
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Mean of Time to First Clinical Fracture
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Assessment method [9]
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The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
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Timepoint [9]
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over 3 years of study duration
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Secondary outcome [10]
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Change in Height at Years 7, 8 and 9 Relative to Year 6
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Assessment method [10]
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Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.
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Timepoint [10]
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Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
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Eligibility
Key inclusion criteria
- Women who have received the 4th and 6th dose of zoledronic acid in study
CZOL446H2301E1
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2013
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Sample size
Target
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Accrual to date
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Final
190
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - St. Leonards
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Recruitment hospital [2]
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Novartis Investigative Site - Geelong
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Recruitment hospital [3]
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Maine
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United States of America
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New Mexico
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United States of America
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North Dakota
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United States of America
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Pennsylvania
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Belgium
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Gent
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Quebec
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Medellín
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Finland
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Helsinki
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France
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Lyon
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Germany
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Berlin
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Germany
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Braunfels
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Germany
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Hannover
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Germany
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Magdeburg
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Germany
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Muenchen
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Hong Kong
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Hong Kong
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Italy
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GE
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Italy
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PD
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Italy
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SI
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Italy
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VR
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New Zealand
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Auckland
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Bergen
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Norway
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Hamar
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Norway
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Oslo
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Poland
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Bialystok
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Poland
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Warsaw
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Poland
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Warszawa
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Sweden
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Goteborg
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Sweden
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Stockholm
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Bern
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Switzerland
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Zuerich
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Thailand
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Chaingmai
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Thailand
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Khonkaen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This second extension will evaluate the efficacy and long term safety of zoledronic acid in
women with post-menopausal osteoporosis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00718861
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00718861
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