3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

Post-menopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718861
• Other study ID #: CZOL446H2301E2
• Secondary ID: 2007-005383-27
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: October 2, 2014
• Start date: May 2008
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationArgentina: Ministry of HealthCanada: Canadian Institutes of Health ResearchColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosNew Zealand: MedsafeNorway: Norwegian Medicines AgencyRussia: Ministry of Health of the Russian FederationSwitzerland: SwissmedicThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-menopausal Osteoporosis

Intervention

Drug:
• Placebo

• Zoledronic acid

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	St. Leonards	New South Wales
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Sainte-Foy	Quebec
Canada	Novartis Investigative Site	Vancouver	British Columbia
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Medellín
Finland	Novartis Investigative Site	Helsinki
France	Novartis Investigative Site	Lyon
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Braunfels
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Muenchen
Hong Kong	Novartis Investigative Site	Hong Kong
Hungary	Novartis Investigative Site	Balatonfured
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyor
Italy	Novartis Investigative Site	Arenzano	GE
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Valeggio Sul Mincio	VR
New Zealand	Novartis Investigative Site	Grafton	Auckland
Norway	Novartis Investigative Site	Bergen
Norway	Novartis Investigative Site	Hamar
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Oslo
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Warsaw
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Zuerich
Thailand	Novartis Investigative Site	Chaingmai
Thailand	Novartis Investigative Site	Khonkaen
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Bangor	Maine
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Gainesville	Georgia
United States	Novartis Investigative Site	Indiamapolis	Indiana
United States	Novartis Investigative Site	Lakewood	Colorado
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Colombia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Italy,  New Zealand,  Norway,  Poland,  Sweden,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Year 6 (baseline) and Year 9	No
Secondary	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.	Year 6 (extension 2 baseline), Year 7, Year 8	No
Secondary	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.	Year 6 (extension 2 baseline), Year 7, Year 8, Year 9	No
Secondary	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.	Year 0 (core baseline), Year 7, Year 8, Year 9	No
Secondary	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.	Year 0 (core baseline), Year 7, Year 8, Year 9	No
Secondary	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	Year 6 (extension 2 baseline), Year 7, Year 8, Year 9	No
Secondary	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.	Year 6 (extension 2 baseline), Year 7, Year 8, Year 9	No
Secondary	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.	Year 6 (extension 2 baseline), Year 7, Year 8, Year 9	No
Secondary	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.	Year 6 (extension 2 baseline), Year 9 (3 years of study duration)	No
Secondary	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.	over 3 years of study duration	No
Secondary	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.	Year 6 (extension 2 baseline), Year 7, Year 8, Year 9	No