Involutional osteoporosis
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Ajinomoto Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 has passed since the last natural menstruation
Exclusion criteria
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-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Primary timeframeFor 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) Secondary timeframe12 months | — |
Contacts
Public Contact; ;
Takeda Pharmaceutical Company Limited;Ajinomoto Pharmaceuticals Co., Ltd.
Outcome results
None listed