Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00439647

First received: February 22, 2007

Last updated: October 10, 2011

Last verified: October 2011

History of Changes

Results First Received: October 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Male Osteoporosis
Interventions:	Drug: Zoledronic acid 5 mg iv Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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	100 ml Placebo 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.

Participant Flow: Overall Study

	Zoledronic Acid	Placebo
STARTED	588 ^[1]	611
Modified Intent to Treat (mITT)	553	574
COMPLETED	530	540
NOT COMPLETED	58	71
Withdrawal by Subject	25	22
Death	15	18
Adverse Event	11	11
Lost to Follow-up	4	12
Protocol Violation	3	4
Lack of Efficacy	0	4

[1]	"Started" indicates intent to treat (ITT) and safety set.

Baseline Characteristics

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Reporting Groups

	Description
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	100 ml Placebo 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.
Total	Total of all reporting groups

Baseline Measures

	Zoledronic Acid	Placebo	Total
Number of Participants [units: participants]	588	611	1199
Age [units: years] Mean ± Standard Deviation	65.8 ± 8.3	65.7 ± 8.6	65.8 ± 8.5
Gender [units: participants]
Female	0	0	0
Male	588	611	1199

Outcome Measures

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1. Primary:

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

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2. Secondary:

Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months [ Time Frame: 12 Months ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

Number of Participants With First Non-vertebral Fracture [ Time Frame: 24 months ]

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Novartis Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

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;367(18):1714-23. doi: 10.1056/NEJMoa1204061.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00439647 History of Changes
Other Study ID Numbers:	CZOL446M2309
Study First Received:	February 22, 2007
Results First Received:	October 10, 2011
Last Updated:	October 10, 2011
Health Authority:	Argentina: National Administration of Drugs, Foods and Medical Technology Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: National Health Surveillance Agency Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Norway: Norwegian Medicines Agency Portugal: National Pharmacy and Medicines Institute Romania: Ministry of Health and the Family Spain: Spanish Agency of Medicines Slovakia: State Institute for Drug Control Sweden: Medical Products Agency Switzerland: Swiss Agency for Therapeudic Products United Kingdom: Medicines and Healthcare Products Regulatory Agency South Africa: Medicines Control Council (MCC) Iceland:"Lyfjastofnun" Icelandic Medicines Control Agency Poland: Central Register of Clinical Trials. The office for Registration of Medicinal Products, Medical Devices and Biocidal Products Italy: Ministero della Salute Austria: Bundesamt für Sicherheit im Gesundheitswesen. AGES PharmMed, WIN/NATA Australia:Therapeutic Goods Administration (TGA) Russia:Federal Service on Surveillance in Healthcare and Social Development of Russian Federation

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