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

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ClinicalTrials.gov Identifier: NCT00439647
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : November 16, 2011
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Male Osteoporosis Drug: Zoledronic acid 5 mg iv Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Zoledronic acid 5 mg iv
Zoledronic acid 5 mg iv given once a year.
Other Names:
  • Aclasta,
  • Reclast
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.
 Drug: Placebo
Placebo intravenous (i.v.) once a year


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months [ Time Frame: 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

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

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

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

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

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

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

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

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

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

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

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

  13. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439647


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Novartis Pharmaceuticals Novartis Argentina
Principal Investigator: Novartis Pharmaceuticals Novartis Belgium
Principal Investigator: Novartis Pharmaceuticals Novartis Brazil
Principal Investigator: Novartis Pharmaceuticals Novartis Czech Republic
Principal Investigator: Novartis Pharmaceuticals Novartis Denmark
Principal Investigator: Novartis Pharmaceuticals Novartis Finland
Principal Investigator: Novartis Pharmaceuticals Novartis Germany
Principal Investigator: Novartis Pharmaceuticals Novartis Hungary
Principal Investigator: Novartis Pharmaceuticals Novartis Norway
Principal Investigator: Novartis Pharmaceuticals Novartis Portugal
Principal Investigator: Novartis Pharmaceuticals Novartis Romania
Principal Investigator: Novartis Pharmaceuticals Novartis Spain
Principal Investigator: Novartis Pharmaceuticals Novartis Slovakia
Principal Investigator: Novartis Pharmaceuticals Novartis Sweden
Principal Investigator: Novartis Pharmaceuticals Novartis
Principal Investigator: Novartis Pharmaceuticals Novartis United Kingdom
Principal Investigator: Novartis Pharmaceuticals Novartis Australia
Principal Investigator: Novartis Pharmaceuticals Novartis Italy
Principal Investigator: Novartis Pharmaceuticals Novartis Austria
Principal Investigator: Novartis Pharmaceuticals Novartis Iceland
Principal Investigator: Novartis Pharmaceuticals Novartis Poland
Principal Investigator: Novartis Pharmaceuticals Novartis Russia
Principal Investigator: Novartis Pharmaceuticals Novartis (South Africa)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00439647    
Other Study ID Numbers: CZOL446M2309
First Posted: February 23, 2007    Key Record Dates
Results First Posted: November 16, 2011
Last Update Posted: April 21, 2017
Last Verified: October 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Osteoporosis
males
vertebral fractures
clinical fractures
 bone mineral density
bone biomarkers
zoledronic acid
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs