Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

Otsuka

Status and phase: Completed; Phase 2

Conditions: Pain Due to Osteoporosis

Treatments: Drug: OPC-249

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504426

249-06-002OD

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Female

Ages: 46 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: OPC-249

2

Active Comparator group

Treatment:

Drug: OPC-249

3

Active Comparator group

Treatment:

Drug: OPC-249

4

Active Comparator group

Treatment:

Drug: OPC-249