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

April 19, 2017 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Cordoba, Argentina
        • Novartis Investigative Site
      • Mar del Plata, Argentina
        • Novartis Investigative Site
      • San Miguel de Tucuman, Argentina
        • Novartis Investigative Site
  • Australia
      • Geelong-VIC, Australia
        • Novartis Investigative Site
      • Maroochydore-QLD, Australia
        • Novartis Investigative Site
      • Randwick-NSW, Australia
        • Novartis Investigative Site
  • Austria
      • Graz, Austria
        • Novartis Investigative Site
      • Vienna, Austria
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium
        • Novartis Investigative Site
      • Diepenbeek, Belgium
        • Novartis Investigative Site
      • Genk, Belgium
        • Novartis Investigative Site
      • Godinne, Belgium
        • Novartis Investigative Site
      • Gozee, Belgium
        • Novartis Investigative Site
      • Jette, Belgium
        • Novartis Investigative Site
      • Laeken, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Liege, Belgium
        • Novartis Investigative Site
      • Merksem, Belgium
        • Novartis Investigative Site
      • Wilrijk, Belgium
        • Novartis Investigative Site
  • Brazil
      • Brasilia, Brazil
        • Novartis Investigative Site
      • Curitiba, Brazil
        • Novartis Investigative Site
      • Rio de Janeiro, Brazil
        • Novartis Investigative Site
      • Sao Paulo, Brazil
        • Novartis Investigative Site
  • Czechia
      • Ceske Budejovice, Czechia
        • Novartis Investigative Site
      • Hradec Kralove, Czechia
        • Novartis Investigative Site
      • Plzen, Czechia
        • Novartis Investigative Site
      • Prague, Czechia
        • Novartis Investigative Site
      • Praha, Czechia
        • Novartis Investigative Site
  • Denmark
      • Aalborg, Denmark
        • Novartis Investigative Site
      • Arhus, Denmark
        • Novartis Investigative Site
      • Glostrup, Denmark
        • Novartis Investigative Site
      • Hvidovre, Denmark
        • Novartis Investigative Site
      • Odense C, Denmark
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland
        • Novartis Investigative Site
      • Tampere, Finland
        • Novartis Investigative Site
      • Turku, Finland
        • Novartis Investigative Site
  • Germany
      • Aachen, Germany
        • Novartis Investigative Site
      • Bad Bentheim, Germany
        • Novartis Investigative Site
      • Bad Pyrmont, Germany
        • Novartis Investigative Site
      • Braunfels, Germany
        • Novartis Investigative Site
      • Dresden, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Hannover, Germany
        • Novartis Investigative Site
      • Heidelberg, Germany
        • Novartis Investigative Site
      • Kempen, Germany
        • Novartis Investigative Site
      • Leverkusen, Germany
        • Novartis Investigative Site
      • Magdeburg, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • München, Germany
        • Novartis Investigative Site
      • Würzburg, Germany
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
      • Debrecen, Hungary
        • Novartis Investigative Site
      • Gyula, Hungary
        • Novartis Investigative Site
      • Szekesfehervar, Hungary
        • Novartis Investigative Site
      • Veszprem, Hungary
        • Novartis Investigative Site
  • Iceland
      • Kopavogur, Iceland
        • Novartis Investigative Site
  • Italy
      • Arenzano, Italy
        • Novartis Investigative Site
      • Siena-SI, Italy
        • Novartis Investigative Site
      • Valeggio Sul Mincio, Italy
        • Novartis Investigative Site
  • Norway
      • Elverum, Norway
        • Novartis Investigative Site
      • Gjettum, Norway
        • Novartis Investigative Site
      • Hamar, Norway
        • Novartis Investigative Site
      • Oslo, Norway
        • Novartis Investigative Site
      • Paradis, Norway
        • Novartis Investigative Site
      • Trondheim, Norway
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland
        • Novartis Investigative Site
      • Warszawa, Poland
        • Novartis Investigative Site
  • Portugal
      • Lisbon, Portugal
        • Novartis Investigative Site
      • Ponte de Lima, Portugal
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania
        • Novartis Investigative Site
      • Cluj Napoca, Romania
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation
        • Novartis Investigative Site
      • Tyumen, Russian Federation
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation
        • Novartis Investigative Site
      • Yekaterinburg, Russian Federation
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Novartis Investigative Site
      • Bratislava, Slovakia
        • Novartis Investigative Site
      • Kosice, Slovakia
        • Novartis Investigative Site
      • Lubochna, Slovakia
        • Novartis Investigative Site
      • Piestany, Slovakia
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa
        • Novartis Investigative Site
      • Rosebank-Johannesburg, South Africa
        • Novartis Investigative Site
      • Western Cape, South Africa
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain
        • Novartis Investigative Site
      • Barcelona, Spain
        • Novartis Investigative Site
      • Cordoba, Spain
        • Novartis Investigative Site
      • Granada, Spain
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Merida, Spain
        • Novartis Investigative Site
      • Oviedo, Spain
        • Novartis Investigative Site
      • Sabadell, Spain
        • Novartis Investigative Site
      • Salamanca, Spain
        • Novartis Investigative Site
      • Santander, Spain
        • Novartis Investigative Site
      • Sevilla, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
      • Villajoyosa, Spain
        • Novartis Investigative Site
  • Sweden
      • Gothenburg, Sweden
        • Novartis Investigative Site
      • Linkoeping, Sweden
        • Novartis Investigative Site
      • Lund, Sweden
        • Novartis Investigative Site
      • Malmo, Sweden
        • Novartis Investigative Site
      • Orebro, Sweden
        • Novartis Investigative Site
      • Stockholm, Sweden
        • Novartis Investigative Site
      • Umea, Sweden
        • Novartis Investigative Site
      • Uppsala, Sweden
        • Novartis Investigative Site
  • Switzerland
      • Aarau, Switzerland
        • Novartis Investigative Site
      • Baden, Switzerland
        • Novartis Investigative Site
      • Basel, Switzerland
        • Novartis Investigative Site
      • Bern, Switzerland
        • Novartis Investigative Site
      • Geneve, Switzerland
        • Novartis Investigative Site
      • Lausanne, Switzerland
        • Novartis Investigative Site
      • Sion, Switzerland
        • Novartis Investigative Site
      • Zuerich, Switzerland
        • Novartis Investigative Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Novartis Investigative Site
      • Chorley, United Kingdom
        • Novartis Investigative Site
      • Glasgow, United Kingdom
        • Novartis Investigative Site
      • Kent, United Kingdom
        • Novartis Investigative Site
      • Liverpool, United Kingdom
        • Novartis Investigative Site
      • Manchester, United Kingdom
        • Novartis Investigative Site
      • Middx, United Kingdom
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom
        • Novartis Investigative Site
      • Nottingham, United Kingdom
        • Novartis Investigative Site
      • Penarth, United Kingdom
        • Novartis Investigative Site
      • Reading-Berkshire, United Kingdom
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Reclast
  • Aclasta,
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 Months
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.
12 months
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.
24 Months
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)
Baseline, 12 months
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)
Baseline, Month 24
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
from Baseline to 12 months and 24 months
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.
24 months
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.
24 months
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.
24 months
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)
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
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)
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
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)
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
Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Novartis Pharmaceuticals, Novartis
  • 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 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CZOL446M2309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings