A phase II/III multicenter, randomized, double-blind, parallel group comparative study to evaluate the efficacy and safety of oral administration of NE-58095NF tablets versus once-daily oral administration of NE-58095 2.5-mg tablets for the treatment of involutional osteoporosis
- Conditions
- Involutional osteoporosis
- Registration Number
- JPRN-jRCT2080222389
- Lead Sponsor
- Ajinomoto Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 760
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 has passed since the last natural menstruation
- 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-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>- Mean bone mineral density of the lumbar spine (L2- L4) determined by DXA[Evaluation endpoint: percent change from baseline at the end of the treatment period]<br>Safety<br>- Adverse events, vital signs, and laboratory parameters
- Secondary Outcome Measures
Name Time Method Efficacy<br>- Mean bone mineral density of the lumbar spine (L2-L4) determined by DXA (evaluation endpoint: percent change from baseline at the end of the treatment period)<br>- Mean bone mineral density of the femur (whole bone, trochanteric region, and neck region) determined by DXA (evaluation endpoint: percent change from baseline at each evaluation time point during the treatment period)<br>- Biochemical bone metabolic markers (evaluation endpoint: percent change from baseline at each evaluation time point during the treatment period)<br>- Incidence of non-traumatic new vertebral body fractures (including worsening of existing fractures) (evaluation endpoint: incidence of non-traumatic vertebral body fractures during the treatment period)