Future and ongoing randomized controlled studies on discontinuation of denosumab treatment
| Study No. . | Setting . | No. of patients, estimated . | Design . | Primary outcome . | Further outcomes . |
|---|---|---|---|---|---|
| NCT03755193 | Postmenopausal osteoporosis | 90 | Treatment with BP, SERM, or calcitriol after 2 y of denosumab | BMD changes (LS, TH) | NA |
| NCT04177940 | GIO | 45 | Treatment with ALN, or early ZOLa, or late ZOLb | BTM changes at various time points after random assignment | NA |
| NCT03868033 | Postmenopausal osteoporosis | 100 | Continuous treatment with denosumab for 2 y, or 1 y ZOL followed by 1 y denosumab, or continuous treatment with ZOL for 2 y, or treatment with ZOL for 1 y followed by close observation | BMD changes (TH, FN) | i) BMD changes (LS) ii) BTMs changes iii) incidence of clinical osteoporotic Fx |
| NCT03396315 | Idiopathic osteoporosis | 34 | Treatment with ALN for 1 y or 1 infusion of ZOL after 1-3 y of denosumab | BMD changes (LS) | NA |
| NCT03623633 | Postmenopausal osteoporosis | 50 | Treatment with ALN or raloxifene after 2 y of denosumab | BTM changes at various time points after random assignment | NA |
| Study No. . | Setting . | No. of patients, estimated . | Design . | Primary outcome . | Further outcomes . |
|---|---|---|---|---|---|
| NCT03755193 | Postmenopausal osteoporosis | 90 | Treatment with BP, SERM, or calcitriol after 2 y of denosumab | BMD changes (LS, TH) | NA |
| NCT04177940 | GIO | 45 | Treatment with ALN, or early ZOLa, or late ZOLb | BTM changes at various time points after random assignment | NA |
| NCT03868033 | Postmenopausal osteoporosis | 100 | Continuous treatment with denosumab for 2 y, or 1 y ZOL followed by 1 y denosumab, or continuous treatment with ZOL for 2 y, or treatment with ZOL for 1 y followed by close observation | BMD changes (TH, FN) | i) BMD changes (LS) ii) BTMs changes iii) incidence of clinical osteoporotic Fx |
| NCT03396315 | Idiopathic osteoporosis | 34 | Treatment with ALN for 1 y or 1 infusion of ZOL after 1-3 y of denosumab | BMD changes (LS) | NA |
| NCT03623633 | Postmenopausal osteoporosis | 50 | Treatment with ALN or raloxifene after 2 y of denosumab | BTM changes at various time points after random assignment | NA |
Abbreviations: ALN, alendronate; BMD, bone mineral density; BP, bisphosphonate; BTMs, bone turnover markers; CTX, C-terminal-cross-linking telopeptide of type 1; FN, femoral neck; Fx, fractures; GIO, glucocorticoid-induced osteoporosis; LS, lumbar spine; NA, not available; SERM, selective estrogen receptor modulator; TH, total hip; ZOL, zoledronate.
aEarly ZOL: zoledronate infusion (5 mg; 6 mo after last denosumab dose).
bLate ZOL: zoledronate infusion (5 mg; 9 mo after last denosumab dose).
Future and ongoing randomized controlled studies on discontinuation of denosumab treatment
| Study No. . | Setting . | No. of patients, estimated . | Design . | Primary outcome . | Further outcomes . |
|---|---|---|---|---|---|
| NCT03755193 | Postmenopausal osteoporosis | 90 | Treatment with BP, SERM, or calcitriol after 2 y of denosumab | BMD changes (LS, TH) | NA |
| NCT04177940 | GIO | 45 | Treatment with ALN, or early ZOLa, or late ZOLb | BTM changes at various time points after random assignment | NA |
| NCT03868033 | Postmenopausal osteoporosis | 100 | Continuous treatment with denosumab for 2 y, or 1 y ZOL followed by 1 y denosumab, or continuous treatment with ZOL for 2 y, or treatment with ZOL for 1 y followed by close observation | BMD changes (TH, FN) | i) BMD changes (LS) ii) BTMs changes iii) incidence of clinical osteoporotic Fx |
| NCT03396315 | Idiopathic osteoporosis | 34 | Treatment with ALN for 1 y or 1 infusion of ZOL after 1-3 y of denosumab | BMD changes (LS) | NA |
| NCT03623633 | Postmenopausal osteoporosis | 50 | Treatment with ALN or raloxifene after 2 y of denosumab | BTM changes at various time points after random assignment | NA |
| Study No. . | Setting . | No. of patients, estimated . | Design . | Primary outcome . | Further outcomes . |
|---|---|---|---|---|---|
| NCT03755193 | Postmenopausal osteoporosis | 90 | Treatment with BP, SERM, or calcitriol after 2 y of denosumab | BMD changes (LS, TH) | NA |
| NCT04177940 | GIO | 45 | Treatment with ALN, or early ZOLa, or late ZOLb | BTM changes at various time points after random assignment | NA |
| NCT03868033 | Postmenopausal osteoporosis | 100 | Continuous treatment with denosumab for 2 y, or 1 y ZOL followed by 1 y denosumab, or continuous treatment with ZOL for 2 y, or treatment with ZOL for 1 y followed by close observation | BMD changes (TH, FN) | i) BMD changes (LS) ii) BTMs changes iii) incidence of clinical osteoporotic Fx |
| NCT03396315 | Idiopathic osteoporosis | 34 | Treatment with ALN for 1 y or 1 infusion of ZOL after 1-3 y of denosumab | BMD changes (LS) | NA |
| NCT03623633 | Postmenopausal osteoporosis | 50 | Treatment with ALN or raloxifene after 2 y of denosumab | BTM changes at various time points after random assignment | NA |
Abbreviations: ALN, alendronate; BMD, bone mineral density; BP, bisphosphonate; BTMs, bone turnover markers; CTX, C-terminal-cross-linking telopeptide of type 1; FN, femoral neck; Fx, fractures; GIO, glucocorticoid-induced osteoporosis; LS, lumbar spine; NA, not available; SERM, selective estrogen receptor modulator; TH, total hip; ZOL, zoledronate.
aEarly ZOL: zoledronate infusion (5 mg; 6 mo after last denosumab dose).
bLate ZOL: zoledronate infusion (5 mg; 9 mo after last denosumab dose).
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