Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
NCT ID: NCT00439647
Last Updated: 2017-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1199 participants
INTERVENTIONAL
2006-12-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zoledronic Acid
5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Zoledronic acid 5 mg iv
Zoledronic acid 5 mg iv given once a year.
Placebo
100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Placebo
Placebo intravenous (i.v.) once a year
Interventions
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Zoledronic acid 5 mg iv
Zoledronic acid 5 mg iv given once a year.
Placebo
Placebo intravenous (i.v.) once a year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Renal insufficiency
* Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,
* Previous treatment with testosterone, anabolic steroids or growth hormone
* Chronic use of systemic corticosteroids (oral or i.v.) within the last year
* History of any cancer or metastases within the last 5 years
* History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis
* Bilateral hip replacements
50 Years
85 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Argentina
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Belgium
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Brazil
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Czech Republic
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Denmark
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Finland
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Germany
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Hungary
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Norway
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Portugal
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Romania
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Spain
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Slovakia
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Sweden
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis United Kingdom
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Australia
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Italy
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Austria
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Iceland
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Poland
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis Russia
Novartis Pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Novartis (South Africa)
Locations
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Novartis Investigative Site
Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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San Miguel de Tucumán, , Argentina
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Geelong-VIC, , Australia
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Maroochydore-QLD, , Australia
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Randwick-NSW, , Australia
Novartis Investigative Site
Graz, , Austria
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Vienna, , Austria
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Brussels, , Belgium
Novartis Investigative Site
Diepenbeek, , Belgium
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Genk, , Belgium
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Godinne, , Belgium
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Gozée, , Belgium
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Jette, , Belgium
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Laken, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
Novartis Investigative Site
Merksem, , Belgium
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Wilrijk, , Belgium
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Brasília, , Brazil
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Curitiba, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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České Budějovice, , Czechia
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Hradec Králové, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Glostrup Municipality, , Denmark
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Hvidovre, , Denmark
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Odense C, , Denmark
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Aachen, , Germany
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Bad Bentheim, , Germany
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Bad Pyrmont, , Germany
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Braunfels, , Germany
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Dresden, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Kempen, , Germany
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Leverkusen, , Germany
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Magdeburg, , Germany
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Marburg, , Germany
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München, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Kopavogur, , Iceland
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Arenzano, , Italy
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Siena-SI, , Italy
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Valeggio sul Mincio, , Italy
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Elverum, , Norway
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Gjettum, , Norway
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Hamar, , Norway
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Oslo, , Norway
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Paradis, , Norway
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Trondheim, , Norway
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Bialystok, , Poland
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Warsaw, , Poland
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Lisbon, , Portugal
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Ponte de Lima, , Portugal
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Tyumen, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Ľubochňa, , Slovakia
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Piešťany, , Slovakia
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Cape Town, , South Africa
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Rosebank-Johannesburg, , South Africa
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Western Cape, , South Africa
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Alicante, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Granada, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Oviedo, , Spain
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Sabadell, , Spain
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Salamanca, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Villajoyosa, , Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Aarau, , Switzerland
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Baden, , Switzerland
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Basel, , Switzerland
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Bern, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Sion, , Switzerland
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Zurich, , Switzerland
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Aberdeen, , United Kingdom
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Chorley, , United Kingdom
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Glasgow, , United Kingdom
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Kent, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
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Middx, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
Novartis Investigative Site
Penarth, , United Kingdom
Novartis Investigative site
Reading-Berkshire, , United Kingdom
Countries
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References
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Boonen S, Reginster JY, Kaufman JM, Lippuner K, Zanchetta J, Langdahl B, Rizzoli R, Lipschitz S, Dimai HP, Witvrouw R, Eriksen E, Brixen K, Russo L, Claessens F, Papanastasiou P, Antunez O, Su G, Bucci-Rechtweg C, Hruska J, Incera E, Vanderschueren D, Orwoll E. Fracture risk and zoledronic acid therapy in men with osteoporosis. N Engl J Med. 2012 Nov 1;367(18):1714-23. doi: 10.1056/NEJMoa1204061.
Other Identifiers
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CZOL446M2309
Identifier Type: -
Identifier Source: org_study_id
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