Trial · NCT01387672
Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study
NCT01387672, Phase 3, Completed, University of Toronto; results first posted 2015-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study. Trials, record NCT01387672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study
- NCT number
- NCT01387672
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 265 participants, actual
- Lead sponsor
- University of Toronto
- Conditions
- Osteoporosis
- Interventions
- Nitrates (NABT Main trial), Placebo
- First posted
- 2011-07-04
- Last updated
- 2015-05-08
- Results first posted
- 2015-05-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Turnover Markers | 3 months | Markers of Bone Formation: * Serum Procollagen type 1 amino- terminal propeptide (P1NP) * Serum Osteocalcin (OC) * Serum Bone-specific alkaline phosphatase (BALP) Markers of Bone Resorption: \- Serum C-telopeptides of collagen cross-links (CTX) |
| Secondary | Headache | Run-in phase - 2 days | Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from "0" to "10". A vertical line marked at "0" means no headache (score recorded = "0"), a vertical line marked at "10" means a terrible headache (score recorded = "10"). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Turnover Markers | 3 months | One subject from the Treatment Arm 3 had outlier bone turnover markers values and was excluded from the analysis. Total number of subjects analyzed in Treatment Arm 3 was therefore 32. | Percent change from baseline | MEAN |
| SECONDARY | Headache | Run-in phase - 2 days | The mean headache score considering all subjects in each of the treatment/formulation group was calculated. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Turnover Markers | ISMO - Treatment Arm 1 | P1NP | -4.627 | Standard Deviation 16.191 | Percent change from baseline |
| Bone Turnover Markers | Patch (Nitro-Dur) - Treatment Arm 2 | P1NP | -0.405 | Standard Deviation 20.289 | Percent change from baseline |
| Bone Turnover Markers | Ointment (Nitrol) - Treatment Arm 3 | P1NP | -4.297 | Standard Deviation 16.236 | Percent change from baseline |
| Bone Turnover Markers | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | P1NP | -6.126 | Standard Deviation 16.093 | Percent change from baseline |
| Bone Turnover Markers | 0.6 Sublingual (Nitrostat 2) - Treatment Arm 5 | P1NP | 2.941 | Standard Deviation 36.843 | Percent change from baseline |
| Bone Turnover Markers | Placebo Ointment - Treatment Arm 6 | P1NP | -1.635 | Standard Deviation 16.749 | Percent change from baseline |
| Bone Turnover Markers | ISMO - Treatment Arm 1 | OC | -3.244 | Standard Deviation 12.049 | Percent change from baseline |
| Bone Turnover Markers | Patch (Nitro-Dur) - Treatment Arm 2 | OC | 3.796 | Standard Deviation 33.601 | Percent change from baseline |
| Bone Turnover Markers | Ointment (Nitrol) - Treatment Arm 3 | OC | -4.481 | Standard Deviation 14.823 | Percent change from baseline |
| Bone Turnover Markers | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | OC | 1.046 | Standard Deviation 21.818 | Percent change from baseline |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ISMO - Treatment Arm 1 | 39 | |
| Overall Study | STARTED | Patch (Nitro-Dur) - Treatment Arm 2 | 38 | |
| Overall Study | STARTED | Ointment (Nitrol) - Treatment Arm 3 | 38 | |
| Overall Study | STARTED | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | 39 | |
| Overall Study | STARTED | 0.6 Sublingual (Nitrostat 2) - Treatment Arm 5 | 38 | |
| Overall Study | STARTED | Placebo Ointment - Treatment Arm 6 | 37 | |
| Overall Study | COMPLETED | ISMO - Treatment Arm 1 | 32 | |
| Overall Study | COMPLETED | Patch (Nitro-Dur) - Treatment Arm 2 | 31 | |
| Overall Study | COMPLETED | Ointment (Nitrol) - Treatment Arm 3 | 33 | |
| Overall Study | COMPLETED | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | ISMO - Treatment Arm 1 | 17 | 39 | 17 |
| other | Headache | Nervous system disorders | Patch (Nitro-Dur) - Treatment Arm 2 | 21 | 38 | 21 |
| other | Headache | Nervous system disorders | Ointment (Nitrol) - Treatment Arm 3 | 17 | 38 | 17 |
| other | Headache | Nervous system disorders | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | 10 | 39 | 10 |
| other | Headache | Nervous system disorders | 0.6 Sublingual (Nitrostat 2) - Treatment Arm 5 | 12 | 38 | 112 |
| other | Headache | Nervous system disorders | Placebo Ointment- Treatment Arm 6 | 6 | 37 | 6 |
| other | Dizziness | Nervous system disorders | ISMO - Treatment Arm 1 | 1 | 39 | 1 |
| other | Dizziness | Nervous system disorders | Patch (Nitro-Dur) - Treatment Arm 2 | 2 | 38 | 2 |
| other | Dizziness | Nervous system disorders | Ointment (Nitrol) - Treatment Arm 3 | 1 | 38 | 1 |
| other | Dizziness | Nervous system disorders | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | 0 | 39 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ISMO - Treatment Arm 1 | ||
| Total, all-cause mortality | Patch (Nitro-Dur) - Treatment Arm 2 | ||
| Total, all-cause mortality | Ointment (Nitrol) - Treatment Arm 3 | ||
| Total, all-cause mortality | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | ||
| Total, all-cause mortality | 0.6 Sublingual (Nitrostat 2) - Treatment Arm 5 | ||
| Total, all-cause mortality | Placebo Ointment- Treatment Arm 6 | ||
| Total, other adverse events | ISMO - Treatment Arm 1 | 17 | 39 |
| Total, other adverse events | Patch (Nitro-Dur) - Treatment Arm 2 | 21 | 38 |
| Total, other adverse events | Ointment (Nitrol) - Treatment Arm 3 | 17 | 38 |
| Total, other adverse events | 0.3 Sublingual (Nitrostat 1) - Treatment Arm 4 | 10 | 39 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01387672
GET https://conductscience.org/api/trials/v1/NCT01387672/results?page=2