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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2007-005383-27
Secondary ID [2] 0 0
CZOL446H2301E2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-menopausal Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9 - 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.
Timepoint [1] 0 0
Year 6 (baseline) and Year 9
Secondary outcome [1] 0 0
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6 - 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.
Timepoint [1] 0 0
Year 6 (extension 2 baseline), Year 7, Year 8
Secondary outcome [2] 0 0
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6 - 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.
Timepoint [2] 0 0
Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Secondary outcome [3] 0 0
Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 - 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.
Timepoint [3] 0 0
Year 0 (core baseline), Year 7, Year 8, Year 9
Secondary outcome [4] 0 0
Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 - 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.
Timepoint [4] 0 0
Year 0 (core baseline), Year 7, Year 8, Year 9
Secondary outcome [5] 0 0
Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 - 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
Timepoint [5] 0 0
Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Secondary outcome [6] 0 0
Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 - 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.
Timepoint [6] 0 0
Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Secondary outcome [7] 0 0
Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 - 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.
Timepoint [7] 0 0
Year 6 (extension 2 baseline), Year 7, Year 8, Year 9
Secondary outcome [8] 0 0
Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6 - 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.
Timepoint [8] 0 0
Year 6 (extension 2 baseline), Year 9 (3 years of study duration)
Secondary outcome [9] 0 0
Mean of Time to First Clinical Fracture - The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
Timepoint [9] 0 0
over 3 years of study duration
Secondary outcome [10] 0 0
Change in Height at Years 7, 8 and 9 Relative to Year 6 - 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.
Timepoint [10] 0 0
Year 6 (extension 2 baseline), Year 7, Year 8, Year 9

Eligibility
Key inclusion criteria
- Women who have received the 4th and 6th dose of zoledronic acid in study
CZOL446H2301E1
Minimum age
65 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maine
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
North Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Colombia
State/province [16] 0 0
Barranquilla
Country [17] 0 0
Colombia
State/province [17] 0 0
Bogotá
Country [18] 0 0
Colombia
State/province [18] 0 0
Medellín
Country [19] 0 0
Finland
State/province [19] 0 0
Helsinki
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Braunfels
Country [23] 0 0
Germany
State/province [23] 0 0
Hannover
Country [24] 0 0
Germany
State/province [24] 0 0
Magdeburg
Country [25] 0 0
Germany
State/province [25] 0 0
Muenchen
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Hong Kong
Country [27] 0 0
Hungary
State/province [27] 0 0
Balatonfured
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Debrecen
Country [30] 0 0
Hungary
State/province [30] 0 0
Gyor
Country [31] 0 0
Italy
State/province [31] 0 0
GE
Country [32] 0 0
Italy
State/province [32] 0 0
PD
Country [33] 0 0
Italy
State/province [33] 0 0
SI
Country [34] 0 0
Italy
State/province [34] 0 0
VR
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
Norway
State/province [36] 0 0
Bergen
Country [37] 0 0
Norway
State/province [37] 0 0
Hamar
Country [38] 0 0
Norway
State/province [38] 0 0
Oslo
Country [39] 0 0
Poland
State/province [39] 0 0
Bialystok
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Sweden
State/province [42] 0 0
Goteborg
Country [43] 0 0
Sweden
State/province [43] 0 0
Stockholm
Country [44] 0 0
Switzerland
State/province [44] 0 0
Bern
Country [45] 0 0
Switzerland
State/province [45] 0 0
Zuerich
Country [46] 0 0
Thailand
State/province [46] 0 0
Chaingmai
Country [47] 0 0
Thailand
State/province [47] 0 0
Khonkaen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This second extension will evaluate the efficacy and long term safety of zoledronic acid in
women with post-menopausal osteoporosis
Trial website
https://clinicaltrials.gov/show/NCT00718861
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications