Osteoporosis
Conditions
Interventions
investigational material(s)
Generic name etc : Benet 75 mg Tablets (sodium risedronate)
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage an
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Osteoporosis patients
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events Primary timeframeFor 12 months The frequency of all adverse events observed during the observation period will be tabulated by symptom, type, and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change from baseline in bone density and bone metabolism markers, time course in height and lumbar backache Secondary timeframeBaseline and Month 12 Tabulation of the following parameters for the efficacy analysis set: [1] Change rate in bone density [2] Change rate in bone metabolism markers [3] Time course in height and lumbar backache | — |
Outcome results
None listed