NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142439

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedInvolutional osteoporosis
Date of first enrollment17/2/2014
Target sample size760
Countries of recruitment
Study typeINTERVENTIONAL
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 OutcomeEfficacy - 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 OutcomeEfficacy - 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 minimum50
Age maximum
GenderBOTH
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

Related Information

Contact

public contact
Name Ajinomoto Pharmaceuticals Co., Ltd. Public Relations Group, Corporate Planning Dept.
Address contact_ajis@ajinomoto.com
Telephone
E-mail
Affiliation
public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation
scientific contact
Name Ajinomoto Pharmaceuticals Co., Ltd. Public Relations Group, Corporate Planning Dept.
Address contact_ajis@ajinomoto.com
Telephone
E-mail
Affiliation
scientific contact
Name Takeda Pharmaceutical Company Limited Takeda Development Center Japan, P(continued to "Affiliation")
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation harmaceutical Development Division