Phase 4
Completed N=186
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00355342 ↗
Enrolled (actual)
186
Serious AEs
34.9%
Results posted
Mar 2018
Primary outcomePrimary: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4 — 0.5; 0.2; 0.8; 1.3 Percent Change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4 |
0.5; 0.2; 0.8; 1.3; 1.3; 1.0 | — |
| SECONDARY Percent Change From Baseline in BMD at the Total Hip |
-0.3; -0.4; -0.5; -1.4; -0.8; -2.1 | — |
Eligibility Criteria
Inclusion criteria
- Established clinical history of COPD.
- Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.
- Smoking history of at least 10 pack-years, where both current and former smokers will be eligible.
- Must have at least one native, evaluable hip.
Exclusion criteria
- History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.
Data sourced from ClinicalTrials.gov (NCT00355342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.