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

The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis.

Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.

Inclusion criteria

• Patients with a diagnosis of involutional osteoporosis
• Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
• Women for whom at least 2 years have passed since the last natural menstruation

Exclusion criteria

• Patients with secondary osteoporosis
• Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
• Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
• Patients with a history of radiotherapy to the lumbar spine or the pelvis
• Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
• 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
• Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
• Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
• Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
• Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
• Patients with hypocalcemia
• Patients with hypercalcemia
• Patients with a diagnosis of renal calculus
• Patients with serious renal, hepatic, or cardiac disease
• 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.