Clinical trial NCT00439647: Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
Official title: A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Male Osteoporosis
Keywords: Osteoporosis
males
vertebral fractures
clinical fractures
bone mineral density
bone biomarkers
zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-23
Enrollment: 1199
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.


Eligibility criteria: Inclusion Criteria:

• Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae

Exclusion Criteria:

* Low Vitamin D
* 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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
timeFrame: 24 Months
Secondary outcomes:
measure: Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months
timeFrame: 12 Months
measure: Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months
timeFrame: 12 months
measure: Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months
timeFrame: 24 Months
measure: Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months
timeFrame: Baseline, 12 months
measure: Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months
timeFrame: Baseline, Month 24
measure: Mean Change in Height From Baseline
timeFrame: from Baseline to 12 months and 24 months
measure: Number of Participants With First Clinical Vertebral Fracture
timeFrame: 24 months
measure: Number of Participants With First Clinical Fracture
timeFrame: 24 months
measure: Number of Participants With First Non-vertebral Fracture
timeFrame: 24 months
measure: Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)
timeFrame: Month 6, Month 12, Month 24
measure: Percentage Change From Baseline in Total Hip BMD (g/CM^2)
timeFrame: Month 6, Month 12, Month 24
measure: Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)
timeFrame: Month 6, Month 12, Month 24
measure: Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits
timeFrame: Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
city: Geelong-VIC
country: Australia
facility: Novartis Investigative Site
city: Maroochydore-QLD
country: Australia
facility: Novartis Investigative Site
city: Randwick-NSW
country: Australia
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Diepenbeek
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Godinne
country: Belgium
facility: Novartis Investigative Site
city: Gozee
country: Belgium
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Laeken
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Merksem
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Brasilia
country: Brazil
facility: Novartis Investigative Site
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Ceske Budejovice
country: Czechia
facility: Novartis Investigative Site
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
city: Plzen
country: Czechia
facility: Novartis Investigative Site
city: Prague
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Aalborg
country: Denmark
facility: Novartis Investigative Site
city: Arhus
country: Denmark
facility: Novartis Investigative Site
city: Glostrup
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigative Site
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Bad Bentheim
country: Germany
facility: Novartis Investigative Site
city: Bad Pyrmont
country: Germany
facility: Novartis Investigative Site
city: Braunfels
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kempen
country: Germany
facility: Novartis Investigative Site
city: Leverkusen
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Gyula
country: Hungary
facility: Novartis Investigative Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: Kopavogur
country: Iceland
facility: Novartis Investigative site
city: Arenzano
country: Italy
facility: Novartis Investigative site
city: Siena-SI
country: Italy
facility: Novartis Investigative site
city: Valeggio Sul Mincio
country: Italy
facility: Novartis Investigative site
city: Elverum
country: Norway
facility: Novartis Investigative Site
city: Gjettum
country: Norway
facility: Novartis Investigative Site
city: Hamar
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Paradis
country: Norway
facility: Novartis Investigative Site
city: Trondheim
country: Norway
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative site
city: Warszawa
country: Poland
facility: Novartis Investigative site
city: Lisbon
country: Portugal
facility: Novartis Investigative Site
city: Ponte de Lima
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative site
city: Tyumen
country: Russian Federation
facility: Novartis Investigative site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative site
city: Yekaterinburg
country: Russian Federation
facility: Novartis Investigative site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Lubochna
country: Slovakia
facility: Novartis Investigative site
city: Piestany
country: Slovakia
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative site
city: Rosebank-Johannesburg
country: South Africa
facility: Novartis Investigative site
city: Western Cape
country: South Africa
facility: Novartis Investigative site
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Merida
country: Spain
facility: Novartis Investigative Site
city: Oviedo
country: Spain
facility: Novartis Investigative Site
city: Sabadell
country: Spain
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
city: Santander
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Villajoyosa
country: Spain
facility: Novartis Investigative Site
city: Gothenburg
country: Sweden
facility: Novartis investigative site
city: Linkoeping
country: Sweden
facility: Novartis investigative site
city: Lund
country: Sweden
facility: Novartis investigative site
city: Malmo
country: Sweden
facility: Novartis investigative site
city: Orebro
country: Sweden
facility: Novartis investigative site
city: Stockholm
country: Sweden
facility: Novartis investigative site
city: Umea
country: Sweden
facility: Novartis investigative site
city: Uppsala
country: Sweden
facility: Novartis investigative site
city: Aarau
country: Switzerland
facility: Novartis Investigative Site
city: Baden
country: Switzerland
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Geneve
country: Switzerland
facility: Novartis Investigative site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Sion
country: Switzerland
facility: Novartis Investigative site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Aberdeen
country: United Kingdom
facility: Novartis Investigative Site
city: Chorley
country: United Kingdom
facility: Novartis Investigative site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Kent
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Middx
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Penarth
country: United Kingdom
facility: Novartis Investigative Site
city: Reading-Berkshire
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Argentina
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Belgium
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Brazil
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Czech Republic
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Denmark
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Finland
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Germany
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Hungary
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Norway
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Portugal
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Romania
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Spain
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Slovakia
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Sweden
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis United Kingdom
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Australia
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Italy
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Austria
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Iceland
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Poland
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis Russia
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis (South Africa)
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.