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

NCT00439647 | Completed Phase 3 Results

• 1 other identifier: CZOL446M2309
• Study Type: interventional
• Target: 1,199
• Locations: 22 countries
• Sites: 126

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.

Conditions

Male Osteoporosis

Keywords

Osteoporosis; males; vertebral fractures; clinical fractures; bone mineral density; bone biomarkers; zoledronic acid

Outcome Measures

Primary Outcomes (1)

• 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

  24 Months

Secondary Outcomes (13)

• Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months

  12 Months

• Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months

  12 months

• Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months

  24 Months

• Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months

  Baseline, 12 months

• Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months

  Baseline, Month 24

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Zoledronic acid 5 mg iv DRUG

Zoledronic acid 5 mg iv given once a year.

Also known as: Aclasta,, Reclast

Zoledronic Acid

Placebo DRUG

Placebo intravenous (i.v.) once a year

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (128)

Novartis Investigative Site

Buenos Aires, Argentina

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Córdoba, Argentina

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Mar del Plata, Argentina

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San Miguel de Tucumán, Argentina

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Geelong-VIC, Australia

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Maroochydore-QLD, Australia

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Randwick-NSW, Australia

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Graz, Austria

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Vienna, Austria

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Brussels, Belgium

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Diepenbeek, Belgium

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Genk, Belgium

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Godinne, Belgium

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Gozée, Belgium

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Jette, Belgium

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Laken, Belgium

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Leuven, Belgium

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Liège, Belgium

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Merksem, Belgium

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Wilrijk, Belgium

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Brasília, Brazil

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Curitiba, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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České Budějovice, Czechia

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Hradec Králové, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Aalborg, Denmark

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Aarhus, Denmark

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Glostrup Municipality, Denmark

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Hvidovre, Denmark

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Odense C, Denmark

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Helsinki, Finland

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Tampere, Finland

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Turku, Finland

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Aachen, Germany

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Bad Bentheim, Germany

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Bad Pyrmont, Germany

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Braunfels, Germany

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Dresden, Germany

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Essen, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Hanover, Germany

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Heidelberg, Germany

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Kempen, Germany

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Leverkusen, Germany

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Magdeburg, Germany

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Marburg, Germany

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München, Germany

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Würzburg, Germany

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Budapest, Hungary

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Debrecen, Hungary

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Gyula, Hungary

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Székesfehérvár, Hungary

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Veszprém, Hungary

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Kopavogur, Iceland

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Arenzano, Italy

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Siena-SI, Italy

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Valeggio sul Mincio, Italy

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Elverum, Norway

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Gjettum, Norway

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Hamar, Norway

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Oslo, Norway

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Paradis, Norway

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Trondheim, Norway

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Bialystok, Poland

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Warsaw, Poland

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Lisbon, Portugal

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Ponte de Lima, Portugal

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Bucharest, Romania

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Cluj-Napoca, Romania

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Moscow, Russia

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Saint Petersburg, Russia

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Tyumen, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Košice, Slovakia

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Ľubochňa, Slovakia

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Piešťany, Slovakia

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Cape Town, South Africa

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Rosebank-Johannesburg, South Africa

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Western Cape, South Africa

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Alicante, Spain

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Barcelona, Spain

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Córdoba, Spain

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Granada, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Málaga, Spain

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Mérida, Spain

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Oviedo, Spain

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Sabadell, Spain

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Salamanca, Spain

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Santander, Spain

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Seville, Spain

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Valencia, Spain

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Villajoyosa, Spain

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Gothenburg, Sweden

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Linköping, Sweden

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Lund, Sweden

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Malmo, Sweden

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Örebro, Sweden

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Stockholm, Sweden

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Umeå, Sweden

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Uppsala, Sweden

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Aarau, Switzerland

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Baden, Switzerland

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Basel, Switzerland

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Bern, Switzerland

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Geneva, Switzerland

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Lausanne, Switzerland

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Sion, Switzerland

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Zurich, Switzerland

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Aberdeen, United Kingdom

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Chorley, United Kingdom

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Glasgow, United Kingdom

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Kent, United Kingdom

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Liverpool, United Kingdom

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Manchester, United Kingdom

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Middx, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Nottingham, United Kingdom

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Penarth, United Kingdom

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Reading-Berkshire, United Kingdom

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Related Publications (1)

• 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.

  PMID: 23113482 DERIVED

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Novartis Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 21, 2017
• Results First Posted: November 16, 2011

Record last verified: 2011-10

Locations

PT (2); RU (5); PL (2); BR (4); AU (3); FI (3); DE (16); AR (4); SE (8); CH (8); NO (6); IT (3); RO (2); SL (5); HU (5); IC (1); ZA (3); ES (15); CZ (4); GB (11); BE (11); DK (5)