| Characteristic . | Denosumab group (n = 42) . | Zoledronic acid group (n = 42) . | Reference . |
|---|---|---|---|
| Male:Female | 27:15 | 27:15 | |
| Clinical type of OI (I:III:IV:V) | 14:14:11:3 | 20:8:12:2 | |
| Age (years), mean (SD) | 7.35 (4.16) | 7.57 (4.11) | |
| Height (cm)a, mean (SD) | 121.5 (26.1) | 119.4 (24.2) | |
| Height Z-score, mean (SD) | −1.367 (2.033) | −0.968 (2.110) | |
| Weight (kg)a, mean (SD) | 24.7 (15.0) | 28.1 (17.3) | |
| Weight Z-score, mean (SD) | −0.552 (1.518) | −0.033 (1.376) | |
| BMI (kg/m2)b, mean (SD) | 17.3 (4.2) | 17.4 (4.1) | |
| BMI Z-score, mean (SD) | 0.157 (1.936) | −0.237 (1.223) | |
| Previous fractures times, median (IQR) | 4 (3, 6) | 4 (2, 5) | |
| Patients with previous vertebral fractures (%) | 9 (21.4) | 14 (33.3) | |
| Patients with previous use of bisphosphonates (%) | 6 (14.3) | 8 (19.0) | |
| ALT (U/L), median (IQR) | 13 (11, 19) | 13 (11, 16) | 5 ∼ 90 |
| Cr (E) (μmol/L), median (IQR) | 30 (26, 37) | 34 (27, 39) | 59 ∼ 104 |
| Ca (mmol/L), mean (SD) | 2.49 (0.09) | 2.45 (0.10) | 2.13 ∼ 2.70 |
| P (mmol/L), mean (SD) | 1.64 (0.19) | 1.60 (0.24) | 1.29 ∼ 1.94 |
| ALP (U/L), mean (SD) | 311 (104) | 304 (106) | 58 ∼ 400 |
| β-CTX (ng/mL), mean (SD) | 1.06 (0.31) | 0.97 (0.33) | 0.21 ∼ 0.44 |
| 25OHD (ng/mL), median (IQR) | 30.7 (22.4, 44.3) | 24.0 (18.4, 33.5) | 20.0 ∼ 50.0 |
| PTH (pg/mL), median (IQR) | 26.1 (20.3, 31.2) | 23.3 (16.8, 31.1) | 15.0 ∼ 65.0 |
| LS aBMD (g/cm2)c, mean (SD) | 0.500 (0.185) | 0.541(0.173) | |
| LS aBMD Z-score, mean (SD) | −1.501 (1.844) | −0.953 (2.041) | |
| FN aBMD (g/cm2)c, mean (SD) | 0.461 (0.151) | 0.487 (0.177) | |
| FN aBMD Z-score, mean (SD) | −3.112 (1.958) | −2.587 (2.490) | |
| TROCH aBMD (g/cm2), mean (SD) | 0.377 (0.137) | 0.409 (0.229) | |
| TH aBMD (g/cm2), mean (SD) | 0.479 (0.148) | 0.513 (0.166) |
| Characteristic . | Denosumab group (n = 42) . | Zoledronic acid group (n = 42) . | Reference . |
|---|---|---|---|
| Male:Female | 27:15 | 27:15 | |
| Clinical type of OI (I:III:IV:V) | 14:14:11:3 | 20:8:12:2 | |
| Age (years), mean (SD) | 7.35 (4.16) | 7.57 (4.11) | |
| Height (cm)a, mean (SD) | 121.5 (26.1) | 119.4 (24.2) | |
| Height Z-score, mean (SD) | −1.367 (2.033) | −0.968 (2.110) | |
| Weight (kg)a, mean (SD) | 24.7 (15.0) | 28.1 (17.3) | |
| Weight Z-score, mean (SD) | −0.552 (1.518) | −0.033 (1.376) | |
| BMI (kg/m2)b, mean (SD) | 17.3 (4.2) | 17.4 (4.1) | |
| BMI Z-score, mean (SD) | 0.157 (1.936) | −0.237 (1.223) | |
| Previous fractures times, median (IQR) | 4 (3, 6) | 4 (2, 5) | |
| Patients with previous vertebral fractures (%) | 9 (21.4) | 14 (33.3) | |
| Patients with previous use of bisphosphonates (%) | 6 (14.3) | 8 (19.0) | |
| ALT (U/L), median (IQR) | 13 (11, 19) | 13 (11, 16) | 5 ∼ 90 |
| Cr (E) (μmol/L), median (IQR) | 30 (26, 37) | 34 (27, 39) | 59 ∼ 104 |
| Ca (mmol/L), mean (SD) | 2.49 (0.09) | 2.45 (0.10) | 2.13 ∼ 2.70 |
| P (mmol/L), mean (SD) | 1.64 (0.19) | 1.60 (0.24) | 1.29 ∼ 1.94 |
| ALP (U/L), mean (SD) | 311 (104) | 304 (106) | 58 ∼ 400 |
| β-CTX (ng/mL), mean (SD) | 1.06 (0.31) | 0.97 (0.33) | 0.21 ∼ 0.44 |
| 25OHD (ng/mL), median (IQR) | 30.7 (22.4, 44.3) | 24.0 (18.4, 33.5) | 20.0 ∼ 50.0 |
| PTH (pg/mL), median (IQR) | 26.1 (20.3, 31.2) | 23.3 (16.8, 31.1) | 15.0 ∼ 65.0 |
| LS aBMD (g/cm2)c, mean (SD) | 0.500 (0.185) | 0.541(0.173) | |
| LS aBMD Z-score, mean (SD) | −1.501 (1.844) | −0.953 (2.041) | |
| FN aBMD (g/cm2)c, mean (SD) | 0.461 (0.151) | 0.487 (0.177) | |
| FN aBMD Z-score, mean (SD) | −3.112 (1.958) | −2.587 (2.490) | |
| TROCH aBMD (g/cm2), mean (SD) | 0.377 (0.137) | 0.409 (0.229) | |
| TH aBMD (g/cm2), mean (SD) | 0.479 (0.148) | 0.513 (0.166) |
No significant differences in baseline characteristics were found between denosumab and zoledronic acid groups. Values are given as number (proportion), mean (SD) or median (IQR).
Abbreviations: β-CTX, β-isomerized carboxy-telopeptide of type I collagen; aBMD, areal bone mineral density; ALP, alkaline phosphatase; ALT, alanine aminotransferase; BMI, body mass index; Ca, calcium; Cr, creatinine; FN, femoral neck; IQR, interquartile range.; LS, lumbar spine; OI, osteogenesis imperfecta; ; P, phosphate; PTH, parathyroid hormone; SD, standard deviation; TH, total hip; TROCH, trochanter; 25OHD, 25-hydroxyvitamin D.
aThe reference ranges for height and weight of different ages were based on standardized growth charts for Chinese children and adolescents (30).
bThe reference ranges for BMI of different ages were based on growth curves for Chinese children and adolescents (31).
cThe reference ranges for aBMD at the lumbar spine and femoral neck of different ages were based on a large-sample cross-sectional study in China (28).
| Characteristic . | Denosumab group (n = 42) . | Zoledronic acid group (n = 42) . | Reference . |
|---|---|---|---|
| Male:Female | 27:15 | 27:15 | |
| Clinical type of OI (I:III:IV:V) | 14:14:11:3 | 20:8:12:2 | |
| Age (years), mean (SD) | 7.35 (4.16) | 7.57 (4.11) | |
| Height (cm)a, mean (SD) | 121.5 (26.1) | 119.4 (24.2) | |
| Height Z-score, mean (SD) | −1.367 (2.033) | −0.968 (2.110) | |
| Weight (kg)a, mean (SD) | 24.7 (15.0) | 28.1 (17.3) | |
| Weight Z-score, mean (SD) | −0.552 (1.518) | −0.033 (1.376) | |
| BMI (kg/m2)b, mean (SD) | 17.3 (4.2) | 17.4 (4.1) | |
| BMI Z-score, mean (SD) | 0.157 (1.936) | −0.237 (1.223) | |
| Previous fractures times, median (IQR) | 4 (3, 6) | 4 (2, 5) | |
| Patients with previous vertebral fractures (%) | 9 (21.4) | 14 (33.3) | |
| Patients with previous use of bisphosphonates (%) | 6 (14.3) | 8 (19.0) | |
| ALT (U/L), median (IQR) | 13 (11, 19) | 13 (11, 16) | 5 ∼ 90 |
| Cr (E) (μmol/L), median (IQR) | 30 (26, 37) | 34 (27, 39) | 59 ∼ 104 |
| Ca (mmol/L), mean (SD) | 2.49 (0.09) | 2.45 (0.10) | 2.13 ∼ 2.70 |
| P (mmol/L), mean (SD) | 1.64 (0.19) | 1.60 (0.24) | 1.29 ∼ 1.94 |
| ALP (U/L), mean (SD) | 311 (104) | 304 (106) | 58 ∼ 400 |
| β-CTX (ng/mL), mean (SD) | 1.06 (0.31) | 0.97 (0.33) | 0.21 ∼ 0.44 |
| 25OHD (ng/mL), median (IQR) | 30.7 (22.4, 44.3) | 24.0 (18.4, 33.5) | 20.0 ∼ 50.0 |
| PTH (pg/mL), median (IQR) | 26.1 (20.3, 31.2) | 23.3 (16.8, 31.1) | 15.0 ∼ 65.0 |
| LS aBMD (g/cm2)c, mean (SD) | 0.500 (0.185) | 0.541(0.173) | |
| LS aBMD Z-score, mean (SD) | −1.501 (1.844) | −0.953 (2.041) | |
| FN aBMD (g/cm2)c, mean (SD) | 0.461 (0.151) | 0.487 (0.177) | |
| FN aBMD Z-score, mean (SD) | −3.112 (1.958) | −2.587 (2.490) | |
| TROCH aBMD (g/cm2), mean (SD) | 0.377 (0.137) | 0.409 (0.229) | |
| TH aBMD (g/cm2), mean (SD) | 0.479 (0.148) | 0.513 (0.166) |
| Characteristic . | Denosumab group (n = 42) . | Zoledronic acid group (n = 42) . | Reference . |
|---|---|---|---|
| Male:Female | 27:15 | 27:15 | |
| Clinical type of OI (I:III:IV:V) | 14:14:11:3 | 20:8:12:2 | |
| Age (years), mean (SD) | 7.35 (4.16) | 7.57 (4.11) | |
| Height (cm)a, mean (SD) | 121.5 (26.1) | 119.4 (24.2) | |
| Height Z-score, mean (SD) | −1.367 (2.033) | −0.968 (2.110) | |
| Weight (kg)a, mean (SD) | 24.7 (15.0) | 28.1 (17.3) | |
| Weight Z-score, mean (SD) | −0.552 (1.518) | −0.033 (1.376) | |
| BMI (kg/m2)b, mean (SD) | 17.3 (4.2) | 17.4 (4.1) | |
| BMI Z-score, mean (SD) | 0.157 (1.936) | −0.237 (1.223) | |
| Previous fractures times, median (IQR) | 4 (3, 6) | 4 (2, 5) | |
| Patients with previous vertebral fractures (%) | 9 (21.4) | 14 (33.3) | |
| Patients with previous use of bisphosphonates (%) | 6 (14.3) | 8 (19.0) | |
| ALT (U/L), median (IQR) | 13 (11, 19) | 13 (11, 16) | 5 ∼ 90 |
| Cr (E) (μmol/L), median (IQR) | 30 (26, 37) | 34 (27, 39) | 59 ∼ 104 |
| Ca (mmol/L), mean (SD) | 2.49 (0.09) | 2.45 (0.10) | 2.13 ∼ 2.70 |
| P (mmol/L), mean (SD) | 1.64 (0.19) | 1.60 (0.24) | 1.29 ∼ 1.94 |
| ALP (U/L), mean (SD) | 311 (104) | 304 (106) | 58 ∼ 400 |
| β-CTX (ng/mL), mean (SD) | 1.06 (0.31) | 0.97 (0.33) | 0.21 ∼ 0.44 |
| 25OHD (ng/mL), median (IQR) | 30.7 (22.4, 44.3) | 24.0 (18.4, 33.5) | 20.0 ∼ 50.0 |
| PTH (pg/mL), median (IQR) | 26.1 (20.3, 31.2) | 23.3 (16.8, 31.1) | 15.0 ∼ 65.0 |
| LS aBMD (g/cm2)c, mean (SD) | 0.500 (0.185) | 0.541(0.173) | |
| LS aBMD Z-score, mean (SD) | −1.501 (1.844) | −0.953 (2.041) | |
| FN aBMD (g/cm2)c, mean (SD) | 0.461 (0.151) | 0.487 (0.177) | |
| FN aBMD Z-score, mean (SD) | −3.112 (1.958) | −2.587 (2.490) | |
| TROCH aBMD (g/cm2), mean (SD) | 0.377 (0.137) | 0.409 (0.229) | |
| TH aBMD (g/cm2), mean (SD) | 0.479 (0.148) | 0.513 (0.166) |
No significant differences in baseline characteristics were found between denosumab and zoledronic acid groups. Values are given as number (proportion), mean (SD) or median (IQR).
Abbreviations: β-CTX, β-isomerized carboxy-telopeptide of type I collagen; aBMD, areal bone mineral density; ALP, alkaline phosphatase; ALT, alanine aminotransferase; BMI, body mass index; Ca, calcium; Cr, creatinine; FN, femoral neck; IQR, interquartile range.; LS, lumbar spine; OI, osteogenesis imperfecta; ; P, phosphate; PTH, parathyroid hormone; SD, standard deviation; TH, total hip; TROCH, trochanter; 25OHD, 25-hydroxyvitamin D.
aThe reference ranges for height and weight of different ages were based on standardized growth charts for Chinese children and adolescents (30).
bThe reference ranges for BMI of different ages were based on growth curves for Chinese children and adolescents (31).
cThe reference ranges for aBMD at the lumbar spine and femoral neck of different ages were based on a large-sample cross-sectional study in China (28).
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