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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00718861

Purpose

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

Condition	Intervention	Phase
Post-Menopausal Osteoporosis	Drug: Placebo Drug: Zoledronic acid	Phase III

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Zoledronic acid

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	July 2008
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo
2: Experimental	Drug: Zoledronic acid

Eligibility

Ages Eligible for Study:	68 Years and older
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718861

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446H2301E2
Study First Received:	July 18, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00718861
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Argentina: Ministry of Health; Canada: Canadian Institutes of Health Research; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; New Zealand: Medsafe; Norway: Norwegian Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Switzerland: Swissmedic; Thailand: Ministry of Public Health

Keywords provided by Novartis:

Osteoporosis
zoledronic acid

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009