Table 1.

Summary of the 4 randomized clinical trials comparing different bisphosphonates and 1 study comparing zoledronate vs denosumab specifically in MM

TrialsAnti-MM treatmentType of bisphosphonateNumber of patientsOutcome measures
OtherSREPainOSONJ
Terpos et al 200382  Vincristin-adriamycin-dexamethasone 4 cycles Pamidronate IV vs ibandronate IV 44 More reduction in NTX and TRACP-5b with pamidronate
 
86.9% vs 90.4% no progression of bone diseasea NR NR NR 
Rosen et al 200383b NR Zoledronate IV 4 mg and 8/4 mg vs pamidronate 90 mg IV every 3-4 wk for 24 mo 1648; 1130 breast cancer and 518 MM NR 1.04 for 4 mg zoledronate vs 1.39 events/year for pamidronate (P = .084), no difference in MMc NR NR NR 
Gimsing et al 201084d e Pamidronate 90 mg vs 30 mg IV 504 Similar improvement in physical function 34% vs 36% patientsf Similar improvement in pain  3 vs 0.8%g 
Morgan et al 201085h i Zoledronate 4 mg IV every 3-4 wk vs 1600 mg/d clodronate 1960 NR 27 vs 35% before disease progression; P = .004j NR HR, 0.84; 95% CI 0.74-0.96; P = .0118 4 vs 1% 
Raje et al 201886  k Zoledronate vs denosumab 1718 NR 45 vs 44% on study  HR, 0.90; 95% CI 0.70-1.16, P = .41 3 vs 4%
renal toxicity 17 vs 10% 
TrialsAnti-MM treatmentType of bisphosphonateNumber of patientsOutcome measures
OtherSREPainOSONJ
Terpos et al 200382  Vincristin-adriamycin-dexamethasone 4 cycles Pamidronate IV vs ibandronate IV 44 More reduction in NTX and TRACP-5b with pamidronate
 
86.9% vs 90.4% no progression of bone diseasea NR NR NR 
Rosen et al 200383b NR Zoledronate IV 4 mg and 8/4 mg vs pamidronate 90 mg IV every 3-4 wk for 24 mo 1648; 1130 breast cancer and 518 MM NR 1.04 for 4 mg zoledronate vs 1.39 events/year for pamidronate (P = .084), no difference in MMc NR NR NR 
Gimsing et al 201084d e Pamidronate 90 mg vs 30 mg IV 504 Similar improvement in physical function 34% vs 36% patientsf Similar improvement in pain  3 vs 0.8%g 
Morgan et al 201085h i Zoledronate 4 mg IV every 3-4 wk vs 1600 mg/d clodronate 1960 NR 27 vs 35% before disease progression; P = .004j NR HR, 0.84; 95% CI 0.74-0.96; P = .0118 4 vs 1% 
Raje et al 201886  k Zoledronate vs denosumab 1718 NR 45 vs 44% on study  HR, 0.90; 95% CI 0.70-1.16, P = .41 3 vs 4%
renal toxicity 17 vs 10% 
a

Follow-up, 10 months.

b

Follow-up, 25 months.

c

Defined as pathological fracture, spinal cord compression, need for radiation, or surgery to bone lesions.

d

Median follow-up, 3.4 years.

e

Melphalan and prednisone with or without thalidomide (n = 213), vincristine, doxorubicin, and dexamethasone or cyclophosphamide and dexamethasone, followed by high-dose melphalan and auSCT (n = 289).

f

First SREs were vertebral fractures (n = 38 vs n = 40), surgically treated nonvertebral fractures (5 patients in each group), irradiated osteolytic lesions (n = 14 vs n = 12), new symptomatic osteolytic lesions (n = 27 vs n = 28), and hypercalcemia (1 patient vs 5 patients).

g

Retrospective analysis.

h

Median follow up, 3.7 years.

i

Induction therapies: cyclophosphamide-vincristine-doxorubicin-dexamethasone or cyclophosphamide-thalidomide-dexamethasone (CTD) followed by high-dose therapy plus auSCT for younger/fitter patients (intensive pathway) and melphalan-prednisone or attenuated CTD for older/less fit patients (nonintensive pathway).

j

Defined as vertebral fractures, other fractures, spinal cord compression, need for radiation or surgery to bone lesions, and new osteolytic bone lesions recorded until disease progression.

k

Fifty-two percent treated with a PI, 17% with an immunomodulatory drug, 27% both, and 4% other.

NTX, N-terminal crosslinking telopeptide of type-I collagen, a bone resorption marker; ONJ, osteonecrosis of the jaw; TRACP-5b, tartrate-resistant acid phosphatase type 5b.

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