ICS Systemic Effects: Bone (1)
Chronic systemic CS can lead to osteoporosis
ICS are systemically available ? bone effects may occur and ideally should be quantified
Bone/BMD not studied in 3 pivotal trials or other-wise reported in these sNDAs for this population
Supportive trials, FLTA3001, FLTA3017
- Different population:
- Younger (18 - 50 yrs)
- Pre-menopausal
- Asthmatics (mild/moderate)
- ?BMD in LS (FLTA3001)
- ?BMD proximal femur (FLTA3017)