A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborators: Ajinomoto Pharmaceuticals Co., Ltd.; EA Pharma Co., Ltd.
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

1. Patients with a diagnosis of involutional osteoporosis

2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent

3. Women for whom at least 2 years have passed since the last natural menstruation

Exclusion Criteria:

1. Patients with secondary osteoporosis

2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass

3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)

4. Patients with a history of radiotherapy to the lumbar spine or the pelvis

5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period

6. Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period

7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period

8. Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period

9. Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding

10. Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)

11. Patients with hypocalcemia

12. Patients with hypercalcemia

13. Patients with a diagnosis of renal calculus

14. Patients with serious renal, hepatic, or cardiac disease

15. Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.