['involutional osteoporosis']
['ne-58095 ir', 'ne-58095 ir placebo', 'ne-58095 dr', 'ne-58095 dr placebo']

        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.
      