12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a PTH analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide).

Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

Inclusion Criteria:

• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide

Exclusion Criteria:

• a bone disease other than postmenopausal osteoporosis
• use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study
• creatinine clearance <60 mL/min/1.73 m2
• liver failure
• any type of cancer
• uncontrolled endocrine diseases
• serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
• hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients

Postmenopausal women

Postmenopausal women treated with severe osteoporosis