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Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study (NABT;NABT-B)

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ClinicalTrials.gov Identifier: NCT01387672
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
California Pacific Medical Center
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Sophie Jamal, University of Toronto

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Osteoporosis
Interventions: Drug: Nitrates (NABT Main trial)
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Initial run-in period-subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. There were 265 subjects enrolled in the run-in phase of the study. Out of those, 229 subjects entered the treatment phase of the study, where they were randomized to one of the 6 treatment arms.

Reporting Groups
  Description
ISMO - Treatment Arm 1

Isosorbide Mononitrate 20mg Oral Tablet

Nitrates (NABT Main trial)

Patch (Nitro-Dur) - Treatment Arm 2

Nitroglycerin Extended Release Patch 160mg

Nitrates (NABT Main trial)

Ointment (Nitrol) - Treatment Arm 3

Nitroglycerin Ointment 2% USP

Nitrates (NABT Main trial)

0.3 Sublingual (Nitrostat 1) - Treatment Arm 4

Nitroglycerin 0.3mg Sublingual Tablet

Nitrates (NABT Main trial)

0.6 Sublingual (Nitrostat 2) - Treatment Arm 5

Nitroglycerin 0.6mg Sublingual Tablet

Nitrates (NABT Main trial)

Placebo Ointment - Treatment Arm 6

Placebo Ointment

Nitrates (NABT Main trial)


Participant Flow:   Overall Study
    ISMO - Treatment Arm 1   Patch (Nitro-Dur) - Treatment Arm 2   Ointment (Nitrol) - Treatment Arm 3   0.3 Sublingual (Nitrostat 1) - Treatment Arm 4   0.6 Sublingual (Nitrostat 2) - Treatment Arm 5   Placebo Ointment - Treatment Arm 6
STARTED   39   38   38   39   38   37 
COMPLETED   32   31   33   35   34   37 
NOT COMPLETED   7   7   5   4   4   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ISMO - Treatment Arm 1

Isosorbide Mononitrate 20mg Oral Tablet

Nitrates (NABT Main trial)

Patch (Nitro-Dur) - Treatment Arm 2

Nitroglycerin Extended Release Patch 160mg

Nitrates (NABT Main trial)

Ointment (Nitrol) - Treatment Arm 3

Nitroglycerin Ointment 2% USP

Nitrates (NABT Main trial)

0.3 Sublingual (Nitrostat 1) - Treatment Arm 4

Nitroglycerin 0.3mg Sublingual Tablet

Nitrates (NABT Main trial)

0.6 Sublingual (Nitrostat 2) - Treatment Arm 5

Nitroglycerin 0.6mg Sublingual Tablet

Nitrates (NABT Main trial)

Placebo Ointment - Treatment Arm 6

Placebo Ointment

Placebo: Placebo ointment Nitrates (NABT Main trial)

Total Total of all reporting groups

Baseline Measures
   ISMO - Treatment Arm 1   Patch (Nitro-Dur) - Treatment Arm 2   Ointment (Nitrol) - Treatment Arm 3   0.3 Sublingual (Nitrostat 1) - Treatment Arm 4   0.6 Sublingual (Nitrostat 2) - Treatment Arm 5   Placebo Ointment - Treatment Arm 6   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   38   38   39   38   37   229 
Age 
[Units: Participants]
             
<=18 years   0   0   0   0   0   0   0 
Between 18 and 65 years   19   21   20   23   23   20   126 
>=65 years   20   17   18   16   15   17   103 
Gender 
[Units: Participants]
             
Female   39   38   38   39   38   37   229 
Male   0   0   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
             
Canada   39   38   38   39   38   37   229 


  Outcome Measures

1.  Primary:   Bone Turnover Markers   [ Time Frame: 3 months ]

2.  Secondary:   Headache   [ Time Frame: Run-in phase - 2 days ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Sophie Jamal
Organization: Womens' College Hospital
phone: 416-351-3732 ext 2873
e-mail: sophie.jamal@wchospital.ca


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sophie Jamal, University of Toronto
ClinicalTrials.gov Identifier: NCT01387672     History of Changes
Other Study ID Numbers: 062011
First Submitted: June 30, 2011
First Posted: July 4, 2011
Results First Submitted: February 17, 2015
Results First Posted: May 8, 2015
Last Update Posted: May 8, 2015