NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Involutional osteoporosis
Date of first enrollment	17/2/2014
Target sample size	760
Countries of recruitment
Study type	INTERVENTIONAL
Intervention(s)	Intervention name : NE-58095 Dosage And administration of the intervention : NE-58095NF tablet (3usage, 2dosage) is administered orally. Control intervention name : NE-58095 Dosage And administration of the control intervention : NE-58095 (2.5-mg tablet) is administered orally once daily at time of wakening.

Outcome(s)

Primary Outcome

Efficacy - 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] Safety - Adverse events, vital signs, and laboratory parameters

Secondary Outcome

Efficacy - 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) - 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) - Biochemical bone metabolic markers (evaluation endpoint: percent change from baseline at each evaluation time point during the treatment period) - 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)

Key inclusion & exclusion criteria

Age minimum	50
Age maximum
Gender	BOTH
Include 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 has passed since the last natural menstruation
Exclude 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-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