Phase 2
Completed N=101
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Pain Due to Osteoporosis
Source: ClinicalTrials.gov NCT00504426 ↗
Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Jan 2014
Primary outcomePrimary: Pain (Subjective Symptom) — -37.8; -24.5; -40.5; -29.0 mm
Summary
The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain (Subjective Symptom) |
-37.8; -24.5; -40.5; -29.0 | — |
| SECONDARY Improvement Rate of Pain (Doctor's Judgment) |
69.0; 59.1; 77.8; 66.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who fulfill all of the following items
- Patients with primary osteoporosis
- Patients who have existing 1-4 vertebral fractures
- Patients with back pain persisting for one week or more
- Postmenopausal women between 46 and less than 80 years of age
Data sourced from ClinicalTrials.gov (NCT00504426). 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.