Male OsteoporosisPhase 3NCT00439647
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
A Phase 3 study testing Zoledronic acid 5 mg iv in people with Male Osteoporosis, run by Novartis Pharmaceuticals at 128 sites in 23 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Male Osteoporosis
- What is being tested?
- Zoledronic acid 5 mg iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,199 participants
- Where
- 128 sitesin 23 countries
- Study dates
- Dec 2006to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
128 sites in 23 countries.
128 sites in 23 countries
Germany16 sites
Novartis Investigative Site
Aachen
Novartis Investigative Site
Bad Bentheim
Novartis Investigative Site
Bad Pyrmont
Novartis Investigative Site
Braunfels
Novartis Investigative site
Dresden
Novartis Investigative Site
Essen
Novartis Investigative Site
Frankfurt
Novartis Investigative site
Hamburg
Novartis Investigative Site
Hanover
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Kempen
Novartis Investigative Site
Leverkusen
Novartis Investigative Site
Magdeburg
Novartis Investigative Site
Marburg
Novartis Investigative Site
München
Novartis Investigative Site
Würzburg
Spain15 sites
Novartis Investigative Site
Alicante
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Granada
Novartis Investigative Site
L'Hospitalet de Llobregat
Novartis Investigative Site
Madrid
Novartis Investigative Site
Málaga
Novartis Investigative Site
Mérida
Novartis Investigative Site
Oviedo
Novartis Investigative Site
Sabadell
Novartis Investigative Site
Salamanca
Novartis Investigative Site
Santander
Novartis Investigative Site
Seville
Novartis Investigative Site
Valencia
Novartis Investigative Site
Villajoyosa
Belgium11 sites
Novartis Investigative Site
Brussels
Novartis Investigative Site
Diepenbeek
Novartis Investigative Site
Genk
Novartis Investigative Site
Godinne
Novartis Investigative Site
Gozée
Novartis Investigative Site
Jette
Novartis Investigative Site
Laken
Novartis Investigative Site
Leuven
Novartis Investigative Site
Liège
Novartis Investigative Site
Merksem
Novartis Investigative Site
Wilrijk
United Kingdom11 sites
Novartis Investigative Site
Aberdeen
Novartis Investigative site
Chorley
Novartis Investigative Site
Glasgow
Novartis Investigative Site
Kent
Novartis Investigative Site
Liverpool
Novartis Investigative Site
Manchester
Novartis Investigative Site
Middx
Novartis Investigative Site
Newcastle upon Tyne
Novartis Investigative Site
Nottingham
Novartis Investigative Site
Penarth
Novartis Investigative site
Reading-Berkshire
Sweden8 sites
Novartis investigative site
Gothenburg
Novartis investigative site
Linköping
Novartis investigative site
Lund
Novartis investigative site
Malmö
Novartis investigative site
Örebro
Novartis investigative site
Stockholm
Novartis investigative site
Umeå
Novartis investigative site
Uppsala
Switzerland8 sites
Novartis Investigative Site
Aarau
Novartis Investigative Site
Baden
Novartis Investigative Site
Basel
Novartis Investigative Site
Bern
Novartis Investigative site
Geneva
Novartis Investigative Site
Lausanne
Novartis Investigative site
Sion
Novartis Investigative Site
Zurich
Norway6 sites
Novartis Investigative Site
Elverum
Novartis Investigative Site
Gjettum
Novartis Investigative Site
Hamar
Novartis Investigative Site
Oslo
Novartis Investigative Site
Paradis
Novartis Investigative Site
Trondheim
Denmark5 sites
Novartis Investigative Site
Aalborg
Novartis Investigative Site
Aarhus
Novartis Investigative Site
Glostrup Municipality
Novartis Investigative Site
Hvidovre
Novartis Investigative Site
Odense C
Hungary5 sites
Novartis Investigative Site
Budapest
Novartis Investigative Site
Debrecen
Novartis Investigative Site
Gyula
Novartis Investigative Site
Székesfehérvár
Novartis Investigative Site
Veszprém
Russia5 sites
Novartis Investigative site
Moscow
Novartis Investigative site
Saint Petersburg
Novartis Investigative site
Tyumen
Novartis Investigative site
Yaroslavl
Novartis Investigative site
Yekaterinburg
Slovakia5 sites
Novartis Investigative Site
Banská Bystrica
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Košice
Novartis Investigative site
Ľubochňa
Novartis Investigative Site
Piešťany
Argentina4 sites
Novartis Investigative Site
Buenos Aires
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Mar del Plata
Novartis Investigative Site
San Miguel de Tucumán
Brazil4 sites
Novartis Investigative Site
Brasília
Novartis Investigative Site
Curitiba
Novartis Investigative Site
Rio de Janeiro
Novartis Investigative Site
São Paulo
Czechia4 sites
Novartis Investigative Site
České Budějovice
Novartis Investigative Site
Hradec Králové
Novartis Investigative Site
Pilsen
Novartis Investigative Site
Prague
Australia3 sites
Novartis Investigative Site
Geelong-VIC
Novartis Investigative Site
Maroochydore-QLD
Novartis Investigative Site
Randwick-NSW
Finland3 sites
Novartis Investigative Site
Helsinki
Novartis Investigative Site
Tampere
Novartis Investigative Site
Turku
Italy3 sites
Novartis Investigative site
Arenzano
Novartis Investigative site
Siena-SI
Novartis Investigative site
Valeggio sul Mincio
South Africa3 sites
Novartis Investigative site
Cape Town
Novartis Investigative site
Rosebank-Johannesburg
Novartis Investigative site
Western Cape
Austria2 sites
Novartis Investigative Site
Graz
Novartis Investigative Site
Vienna
Poland2 sites
Novartis Investigative site
Bialystok
Novartis Investigative site
Warsaw
Portugal2 sites
Novartis Investigative Site
Lisbon
Novartis Investigative Site
Ponte de Lima
Romania2 sites
Novartis Investigative Site
Bucharest
Novartis Investigative Site
Cluj-Napoca
About this study
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
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.
- Conditions
- Male Osteoporosis
- Being tested
- Zoledronic acid 5 mg iv, Placebo
- Keywords
- Osteoporosis, males, vertebral fractures, clinical fractures, bone mineral density, bone biomarkers, zoledronic acid
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acid 5 mg ivDrug
Also called Aclasta,, Reclast
Zoledronic acid 5 mg iv given once a year.
PlaceboDrug
Placebo intravenous (i.v.) once a year
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid | Experimental | 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. Receives: Drug: Zoledronic acid 5 mg iv |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
Measured: 24 Months
Secondary outcomes (13)
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months
Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
Measured: 12 Months
Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months
Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A 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. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.
Measured: 12 months
Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months
Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A 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. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.
Measured: 24 Months
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months
Worsening 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 worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)
Measured: Baseline, 12 months
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months
Worsening vertebral fracture (VF) was assessed based on morphometry. A 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 worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)
Measured: Baseline, Month 24
Mean Change in Height From Baseline
Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis
Measured: from Baseline to 12 months and 24 months
Number of Participants With First Clinical Vertebral Fracture
Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.
Measured: 24 months
Number of Participants With First Clinical Fracture
Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.
Measured: 24 months
Number of Participants With First Non-vertebral Fracture
Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.
Measured: 24 months
Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)
Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)
Measured: Month 6, Month 12, Month 24
Percentage Change From Baseline in Total Hip BMD (g/CM^2)
Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)
Measured: Month 6, Month 12, Month 24
Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)
Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)
Measured: Month 6, Month 12, Month 24
Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits
Measured: Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male OsteoporosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Principal investigator, Novartis ArgentinaNovartis Pharmaceuticals, Principal investigator, Novartis BelgiumNovartis Pharmaceuticals, Principal investigator, Novartis BrazilNovartis Pharmaceuticals, Principal investigator, Novartis Czech RepublicNovartis Pharmaceuticals, Principal investigator, Novartis DenmarkNovartis Pharmaceuticals, Principal investigator, Novartis FinlandNovartis Pharmaceuticals, Principal investigator, Novartis GermanyNovartis Pharmaceuticals, Principal investigator, Novartis Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439647
- Sponsor's protocol ID
- CZOL446M2309
- Status last verified
- Oct 2011
- First submitted
- 22 Feb 2007
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 23113482
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00439647
- Acronym / sponsor ID
- CZOL446M2309
- Conditions
- Male Osteoporosis
- Keywords
- Osteoporosis, males, vertebral fractures, clinical fractures, bone mineral density, bone biomarkers, zoledronic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Posted 16 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid | Experimental | Drug: Zoledronic acid 5 mg iv5 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 | Placebo comparator | Drug: Placebo100 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acid 5 mg ivAlso: Aclasta,, ReclastZoledronic acid 5 mg iv given once a year. | Drug | Zoledronic Acid |
| PlaceboPlacebo intravenous (i.v.) once a year | Drug | Placebo |
Primary outcome
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
Time frame: 24 Months
Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
13 secondary outcomes
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months
Time frame: 12 Months
Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months
Time frame: 12 months
Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months
Time frame: 24 Months
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months
Time frame: Baseline, 12 months
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months
Time frame: Baseline, Month 24
Mean Change in Height From Baseline
Time frame: from Baseline to 12 months and 24 months
Number of Participants With First Clinical Vertebral Fracture
Time frame: 24 months
Number of Participants With First Clinical Fracture
Time frame: 24 months
Number of Participants With First Non-vertebral Fracture
Time frame: 24 months
Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)
Time frame: Month 6, Month 12, Month 24
Percentage Change From Baseline in Total Hip BMD (g/CM^2)
Time frame: Month 6, Month 12, Month 24
Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)
Time frame: Month 6, Month 12, Month 24
Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits
Time frame: Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23113482Boonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals principal investigator
Novartis Argentina
Novartis Pharmaceuticals principal investigator
Novartis Belgium
Novartis Pharmaceuticals principal investigator
Novartis Brazil
128 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid 5 mg iv in people with Male Osteoporosis, run by Novartis Pharmaceuticals at 128 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 sites in Germany, Spain, Belgium, United Kingdom, Sweden and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.