Strategies for zoledronic acid post-denosumab discontinuation in postmenopausal osteoporosis

Conditions

Postmenopausal osteoporosis

Brief summary

the proportion of patients who failed: - to maintain lumbar BMD, assessed by dual-energy x-ray absorptiometry (DXA) after 1 year of ZOL. The least significant change in BMD being 0.03 g/cm²; - or presenting an additional vertebral fracture during 1st year.

Detailed description

the proportion of patients who failed to maintain hip BMD after 1 year of ZOL (least significant change: 0.03 g/cm²), the changes in hip and lumbar BMD from baseline to 1 year after ZOL, and from year 1 to year 2, the changes from baseline in bone turnover markers (crosslaps, bone alkalin phosphatase, osteocalcin, amino-terminal propeptide of type 1 procollagen, TRAP5b, dickkopf 1, sclerostin), at year 1 and year 2, the number of morphometric vertebral fractures (by vertebral fracture assessment – VFA or X-rays), of clinical vertebral fractures and of clinical peripheral fractures, at year 1 and year 2, the number of adverse events and serious adverse events at year 1 and year 2, the proportion of patients requiring a second ZOL infusion across groups.

Related papers

No related papers found yet.

Interventions

DRUGACIDE ZOLEDRONIQUE SANDOZ 5 mg/100 ml

DRUGsolution pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
the proportion of patients who failed: - to maintain lumbar BMD, assessed by dual-energy x-ray absorptiometry (DXA) after 1 year of ZOL. The least significant change in BMD being 0.03 g/cm²; - or presenting an additional vertebral fracture during 1st year.	—

Secondary

Measure	Time frame
the proportion of patients who failed to maintain hip BMD after 1 year of ZOL (least significant change: 0.03 g/cm²), the changes in hip and lumbar BMD from baseline to 1 year after ZOL, and from year 1 to year 2, the changes from baseline in bone turnover markers (crosslaps, bone alkalin phosphatase, osteocalcin, amino-terminal propeptide of type 1 procollagen, TRAP5b, dickkopf 1, sclerostin), at year 1 and year 2, the number of morphometric vertebral fractures (by vertebral fracture assessment – VFA or X-rays), of clinical vertebral fractures and of clinical peripheral fractures, at year 1 and year 2, the number of adverse events and serious adverse events at year 1 and year 2, the proportion of patients requiring a second ZOL infusion across groups.	—

Measure

Time frame

the proportion of patients who failed to maintain hip BMD after 1 year of ZOL (least significant change: 0.03 g/cm²), the changes in hip and lumbar BMD from baseline to 1 year after ZOL, and from year 1 to year 2, the changes from baseline in bone turnover markers (crosslaps, bone alkalin phosphatase, osteocalcin, amino-terminal propeptide of type 1 procollagen, TRAP5b, dickkopf 1, sclerostin), at year 1 and year 2, the number of morphometric vertebral fractures (by vertebral fracture assessment – VFA or X-rays), of clinical vertebral fractures and of clinical peripheral fractures, at year 1 and year 2, the number of adverse events and serious adverse events at year 1 and year 2, the proportion of patients requiring a second ZOL infusion across groups.

—

Countries

France

Outcome results

None listed