Trial · NCT01745848
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
NCT01745848, Phase 4, Completed, University of Pittsburgh; results first posted 2017-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD. Trials, record NCT01745848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01745848
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
- NCT number
- NCT01745848
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Roflumilast
- First posted
- 2012-12-10
- Last updated
- 2017-08-29
- Results first posted
- 2017-08-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP)) | 30 days - measurements at baseline and 30 days | Serum samples were obtained at baseline and after participants took a once daily, 500 mcg roflumilast dose for 30 days. Samples were obtained in the semi-fasting state, processed, and stored for batch analysis at the end of the study. C-terminal peptide of type 1 collagen (CTx), a marker of bone resorption, was analyzed using a commercially available immunoassay (Roche Elecsys 2010 analyzer, Roche Diagnostics, Manheim, Germany). Serum amino-terminal propeptide of type-1 procollagen (P1NP) was measured by ELISA (MyBioSource, San Diego, CA). All assays were performed according to the manufacturers' instructions. |
| Secondary | Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation | 30 days - measured at baseline and 30 days | Participants had flow mediated dilation of the brachial artery measured at the baseline visit and at the follow-up visit after receiving 30 days of roflumilast 500 mcg daily. An ultrasound probe was placed over the brachial artery and the brachial artery diameter was measured in real time. A blood pressure cuff positioned below the elbow was then inflated to 50 mmHg above systolic pressure for five minutes. After five minutes of occlusion, the blood pressure cuff was released and the brachial artery diameter was again measured in real time. The amount of dilation expressed as the absolute change, in millimeters, from baseline diameter was quantified using the ultrasound images obtained 60 seconds after cuff release. |
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 | Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP)) | 30 days - measurements at baseline and 30 days | Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug. | ng/mL | MEAN |
| SECONDARY | Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation | 30 days - measured at baseline and 30 days | Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug. | millimeters | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP)) | Roflumilast | change in CTx levels from baseline to 30-days | 0.079 | Standard Deviation 0.096 | ng/mL |
| Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP)) | Roflumilast | change in P1NP levels from baseline to 30 days | -101.77 | Standard Deviation 246.53 | ng/mL |
| Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation | Roflumilast | 0.335 | Standard Deviation 4.63 | millimeters |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roflumilast | 26 | |
| Overall Study | COMPLETED | Roflumilast | 20 | |
| Overall Study | NOT COMPLETED | Roflumilast | 6 |
Source ClinicalTrials.gov
Adverse events2
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 | Gastrointestinal upset | Gastrointestinal disorders | Roflumilast | 3 | 26 | 3 |
| other | Gastrointestinal upset | Gastrointestinal disorders | Roflumilast | 3 | 26 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roflumilast | 0 | 26 |
| Total, other adverse events | Roflumilast | 6 | 26 |
| Total, serious adverse events | Roflumilast | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01745848
GET https://conductscience.org/api/trials/v1/NCT01745848/registered