Pain Due to Osteoporosis
Conditions
Brief 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.
Interventions
DRUGOPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
46 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (Subjective Symptom) | Baseline and Week 4 | Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement Rate of Pain (Doctor's Judgment) | Baseline and Week 4 | Percentage of participants qualified for improvement of pain by doctor's judgement. Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend. Improvement defind by stopped or almost stopped or alleviated. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo of OPC-249/vial | 32 |
| OPC-249 (30IU) 30 IU of OPC-249/vial | 23 |
| OPC-249 (60IU) 60 IU of OPC-249/vial | 22 |
| OPC-249 (120IU) 120 IU of OPC-249/vial | 24 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | OPC-249 (30IU) | OPC-249 (60IU) | Placebo | OPC-249 (120IU) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 20 Participants | 28 Participants | 22 Participants | 91 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 10 Participants |
| Age, Continuous | 73.0 years STANDARD_DEVIATION 5.1 | 73.4 years STANDARD_DEVIATION 5.9 | 71.9 years STANDARD_DEVIATION 6 | 72.3 years STANDARD_DEVIATION 5.9 | 72.6 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment Japan | 23 participants | 22 participants | 32 participants | 24 participants | 101 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 32 Participants | 24 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 32 | 9 / 23 | 6 / 22 | 4 / 24 |
| serious Total, serious adverse events | 0 / 32 | 1 / 23 | 0 / 22 | 0 / 24 |
Outcome results
Primary
Pain (Subjective Symptom)
Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable.
Time frame: Baseline and Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain (Subjective Symptom) | -37.8 mm | Standard Deviation 28.7 |
| OPC-249 (30IU) | Pain (Subjective Symptom) | -24.5 mm | Standard Deviation 27.3 |
| OPC-249 (60IU) | Pain (Subjective Symptom) | -40.5 mm | Standard Deviation 26.2 |
| OPC-249 (120IU) | Pain (Subjective Symptom) | -29.0 mm | Standard Deviation 23.7 |
Secondary
Improvement Rate of Pain (Doctor's Judgment)
Percentage of participants qualified for improvement of pain by doctor's judgement. Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend. Improvement defind by stopped or almost stopped or alleviated.
Time frame: Baseline and Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Improvement Rate of Pain (Doctor's Judgment) | 69.0 Percentage of Participants |
| OPC-249 (30IU) | Improvement Rate of Pain (Doctor's Judgment) | 59.1 Percentage of Participants |
| OPC-249 (60IU) | Improvement Rate of Pain (Doctor's Judgment) | 77.8 Percentage of Participants |
| OPC-249 (120IU) | Improvement Rate of Pain (Doctor's Judgment) | 66.7 Percentage of Participants |