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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT00439647
Date of registration:	22/02/2007
Prospective Registration:	No
Primary sponsor:	Novartis Pharmaceuticals
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
Date of first enrolment:	December 2006
Target sample size:	1199
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00439647
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
Argentina	Australia	Austria	Belgium	Brazil	Czech Republic	Czechia	Denmark
Finland	Germany	Hungary	Iceland	Italy	Norway	Poland	Portugal
Romania	Russian Federation	Slovakia	South Africa	Spain	Sweden	Switzerland	United Kingdom

Contacts

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis (South Africa)

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Denmark

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Finland

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Norway

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Portugal

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Romania

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis United Kingdom

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Germany

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Russia

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Czech Republic

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Hungary

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Poland

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Spain

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Sweden

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Argentina

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Australia

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Italy

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Belgium

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Iceland

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Affiliation:	Novartis Austria

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Brazil

Name:	Novartis Pharmaceuticals
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Affiliation:	Novartis Slovakia

Key inclusion & exclusion 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

Age minimum: 50 Years
Age maximum: 85 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Male Osteoporosis

Intervention(s)

Drug: Placebo

Drug: Zoledronic acid 5 mg iv

Primary Outcome(s)

Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months [Time Frame: 24 Months]

Secondary Outcome(s)

Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD) [Time Frame: Month 6, Month 12, Month 24]

Number of Participants With First Clinical Vertebral Fracture [Time Frame: 24 months]

Number of Participants With First Non-vertebral Fracture [Time Frame: 24 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 Morphometric Vertebral Fracture Over 12 Months [Time Frame: 12 Months]

Number of Participants With First Clinical Fracture [Time Frame: 24 months]

Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months [Time Frame: 24 Months]

Percentage Change From Baseline in Total Hip 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]

Mean Change in Height From Baseline [Time Frame: from Baseline to 12 months and 24 months]

Percentage Change From Baseline in Femoral Neck BMD (g/CM^2) [Time Frame: Month 6, Month 12, Month 24]

Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months [Time Frame: Baseline, Month 24]

Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months [Time Frame: Baseline, 12 months]

Secondary ID(s)

CZOL446M2309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	16/11/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00439647

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