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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00439647




Registration number
NCT00439647
Ethics application status
Date submitted
22/02/2007
Date registered
23/02/2007
Date last updated
21/04/2017

Titles & IDs
Public title
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
Scientific 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
Secondary ID [1] 0 0
CZOL446M2309
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic acid 5 mg iv
Treatment: Drugs - Placebo

Experimental: 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.

Placebo comparator: 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.


Treatment: Drugs: Zoledronic acid 5 mg iv
Zoledronic acid 5 mg iv given once a year.

Treatment: Drugs: Placebo
Placebo intravenous (i.v.) once a year
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
Timepoint [1] 0 0
24 Months
Secondary outcome [1] 0 0
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months
Timepoint [3] 0 0
24 Months
Secondary outcome [4] 0 0
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months
Timepoint [4] 0 0
Baseline, 12 months
Secondary outcome [5] 0 0
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months
Timepoint [5] 0 0
Baseline, Month 24
Secondary outcome [6] 0 0
Mean Change in Height From Baseline
Timepoint [6] 0 0
from Baseline to 12 months and 24 months
Secondary outcome [7] 0 0
Number of Participants With First Clinical Vertebral Fracture
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Number of Participants With First Clinical Fracture
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Number of Participants With First Non-vertebral Fracture
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)
Timepoint [10] 0 0
Month 6, Month 12, Month 24
Secondary outcome [11] 0 0
Percentage Change From Baseline in Total Hip BMD (g/CM^2)
Timepoint [11] 0 0
Month 6, Month 12, Month 24
Secondary outcome [12] 0 0
Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)
Timepoint [12] 0 0
Month 6, Month 12, Month 24
Secondary outcome [13] 0 0
Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits
Timepoint [13] 0 0
Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24

Eligibility
Key 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
Minimum age
50 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

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
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
1199
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Geelong-VIC
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore-QLD
Recruitment hospital [3] 0 0
Novartis Investigative Site - Randwick-NSW
Recruitment postcode(s) [1] 0 0
- Geelong-VIC
Recruitment postcode(s) [2] 0 0
- Maroochydore-QLD
Recruitment postcode(s) [3] 0 0
- Randwick-NSW
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Cordoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Mar del Plata
Country [4] 0 0
Argentina
State/province [4] 0 0
San Miguel de Tucuman
Country [5] 0 0
Austria
State/province [5] 0 0
Graz
Country [6] 0 0
Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Belgium
State/province [8] 0 0
Diepenbeek
Country [9] 0 0
Belgium
State/province [9] 0 0
Genk
Country [10] 0 0
Belgium
State/province [10] 0 0
Godinne
Country [11] 0 0
Belgium
State/province [11] 0 0
Gozee
Country [12] 0 0
Belgium
State/province [12] 0 0
Jette
Country [13] 0 0
Belgium
State/province [13] 0 0
Laeken
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Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Belgium
State/province [16] 0 0
Merksem
Country [17] 0 0
Belgium
State/province [17] 0 0
Wilrijk
Country [18] 0 0
Brazil
State/province [18] 0 0
Brasilia
Country [19] 0 0
Brazil
State/province [19] 0 0
Curitiba
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio de Janeiro
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Czechia
State/province [22] 0 0
Ceske Budejovice
Country [23] 0 0
Czechia
State/province [23] 0 0
Hradec Kralove
Country [24] 0 0
Czechia
State/province [24] 0 0
Plzen
Country [25] 0 0
Czechia
State/province [25] 0 0
Prague
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha
Country [27] 0 0
Denmark
State/province [27] 0 0
Aalborg
Country [28] 0 0
Denmark
State/province [28] 0 0
Arhus
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Denmark
State/province [29] 0 0
Glostrup
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Denmark
State/province [30] 0 0
Hvidovre
Country [31] 0 0
Denmark
State/province [31] 0 0
Odense C
Country [32] 0 0
Finland
State/province [32] 0 0
Helsinki
Country [33] 0 0
Finland
State/province [33] 0 0
Tampere
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Finland
State/province [34] 0 0
Turku
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Germany
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Aachen
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Germany
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Bad Bentheim
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Germany
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Bad Pyrmont
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Germany
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Braunfels
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Germany
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Dresden
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Germany
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Essen
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Germany
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Frankfurt
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Hamburg
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Heidelberg
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Kempen
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Leverkusen
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
State/province [49] 0 0
München
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Germany
State/province [50] 0 0
Würzburg
Country [51] 0 0
Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Szekesfehervar
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Hungary
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Veszprem
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Iceland
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Kopavogur
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Italy
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Arenzano
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Italy
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Siena-SI
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Italy
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Valeggio Sul Mincio
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Elverum
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Gjettum
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Paradis
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Trondheim
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Bialystok
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Warszawa
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Portugal
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Lisbon
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Portugal
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Ponte de Lima
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Romania
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Bratislava
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Kosice
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Barcelona
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Cordoba
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Hospitalet de Llobregat
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Uppsala
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Basel
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Sion
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Zuerich
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Aberdeen
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Chorley
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United Kingdom
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Glasgow
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United Kingdom
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Kent
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Middx
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Penarth
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United Kingdom
State/province [126] 0 0
Reading-Berkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Argentina
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00439647