Osseous Paget's disease
Conditions
Interventions
investigational material(s)
Generic name etc : Benet 17.5 mg Tablets (sodium risedronate)
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Osseous Paget's disease patients treated with Benet 17.5 mg Tablets
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframeFor 48 weeks The frequencies of all adverse drug reactions observed during the observation period will be tabulated by 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. Among these, events that are considered as having a causal relationship with sodium risedronate are defined as adverse drug reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum ALP, bone metabolism markers, pain associated with osseous Paget's disease, and treatment compliance Secondary timeframeFrom Baseline to Week 48 The following parameters will be tabulated: [1] Rate of changes from Baseline in serum ALP level and bone metabolism markers [2] Distribution of severity of pain associated with osseous Paget's disease [3] Treatment compliance | — |
Outcome results
None listed