. 2019 Jun 24;34(9):1597–1608. doi: 10.1002/jbmr.3735

Table 2.

Dynamic Histomorphometric Parameters of Bone Formation at Baseline and After 2 Months of Romosozumab in Patients With Quadruple Fluorochrome Labeling

		Placebo (N = 18)				Romosozumab 210 mg QM (N = 16)
	n ^a	Baseline ^b	Month 2	Paired p value^c	n ^a	Baseline ^b	Month 2	Paired p value^c
Cancellous bone
Cn‐MAR ^d	14	0.61	0.65	0.84	14	0.59	0.57	0.62
µm/day		(0.56, 0.69)	(0.54, 0.70)			(0.53, 0.65)	(0.51, 0.59)	0.62
Cn‐MAR^e	13	0.61	0.66	0.88	13	0.59	0.57	0.29
µm/day		(0.57, 0.69)	(0.61, 0.70)			(0.54, 0.65)	(0.51, 0.58)	0.29
Cn‐MS/BS	14	1.60	2.31	0.27	15	1.51	5.64	<0.001
%		(0.49, 2.19)	(0.72, 3.14)			(0.57, 3.15)	(3.71, 8.42)	<0.001
Cn‐BFR/BS ^d	14	3.078	5.175	0.24	14	3.381	12.486	<0.001
µm³/µm²/year		(1.307, 5.359)	(2.919, 7.165)			(1.647, 6.776)	(7.734, 16.132)	<0.001
Cn‐BFR/BS^e	13	3.457	5.565	0.31	13	3.584	12.898	<0.001
µm³/µm²/year		(1.648, 5.359)	(4.347, 7.165)			(1.960, 6.776)	(7.788, 16.132)	<0.001
Endocortical bone
Ec‐MAR ^d	12	0.62	0.61	0.65	15	0.62	0.58	0.92
µm/day		(0.53, 0.67)	(0.53, 0.72)			(0.51, 0.66)	(0.56, 0.66)	0.92
Ec‐MAR^e	12	0.62	0.61	0.65	14	0.63	0.58	0.55
µm/day		(0.53, 0.67)	(0.53, 0.72)			(0.58, 0.66)	(0.56, 0.62)	0.55
Ec‐MS/BS	14	7.65	7.00	0.24	15	6.26	24.59	<0.001
%		(3.49, 12.14)	(3.27, 9.92)			(3.05, 9.52)	(15.98, 31.50)	<0.001
Ec‐BFR/BS ^d	12	18.715	15.191	0.34	15	14.051	52.260	<0.001
µm³/µm²/year		(12.949, 24.711)	(10.985, 21.197)			(8.251, 24.090)	(33.748, 64.875)	<0.001
Ec‐BFR/BS^e	12	18.715	15.191	0.34	14	14.384	52.361	<0.001
µm³/µm²/year		(12.949, 24.711)	(10.985, 21.197)			(8.506, 24.090)	(35.300, 64.875)	<0.001
Intracortical bone
Ct‐MAR ^d	12	0.64	0.75	0.032	15	0.60	0.67	0.31
µm/day		(0.59, 0.70)	(0.65, 0.85)			(0.55, 0.76)	(0.58, 0.75)	0.31
Ct‐MAR^e	11	0.64	0.76	0.032	15	0.60	0.67	0.31
µm/day		(0.60, 0.73)	(0.66, 0.85)			(0.55, 0.76)	(0.58, 0.75)	0.31
Ct‐MS/BS	14	7.46	4.59	0.95	15	4.89	8.23	0.12
%		(2.73, 11.06)	(1.41, 8.47)			(3.62, 6.51)	(4.99, 10.56)	0.12
Ct‐BFR/BS ^d	12	20.735	17.557	0.68	15	12.515	19.202	0.064
µm³/µm²/year		(8.914, 27.049)	(5.407, 29.472)			(7.425, 15.411)	(13.113, 32.024)	0.064
Ct‐BFR/BS^e	11	22.302	18.383	0.70	15	12.515	19.202	0.064
µm³/µm²/year		(13.074, 30.450)	(7.103, 32.851)			(7.425, 15.411)	(13.113, 32.024)	0.064
Periosteal bone
Ps‐MAR ^d	5	0.24	0.24	1.00	2	0.59	0.24	0.50
µm/day		(0.24, 0.34)	(0.24, 0.55)			(0.40, 0.78)	(0.24, 0.24)	0.50
Ps‐MAR^e	1	0.34	0.55	1.00	0	‐	‐	‐
µm/day		(0.34, 0.34)	(0.55, 0.55)			(−, −)	(−, −)	‐
Ps‐MS/BS	14	0.00	0.07	0.11	15	0.00	0.47	0.083
%		(0.00, 0.59)	(0.00, 1.10)			(0.00, 0.00)	(0.00, 1.64)	0.083
Ps‐BFR/BS ^d	5	0.507	3.195	0.063	2	1.854	0.688	0.50
µm³/µm²/year		(0.206, 1.199)	(2.273, 5.229)			(1.235, 2.473)	(0.189, 1.187)	0.50
Ps‐BFR/BS^e	1	1.199	3.195	1.00	0	‐	‐	‐
µm³/µm²/year		(1.199, 1.199)	(3.195, 3.195)			(−, −)	(−, −)	‐

N = number of randomized patients who enrolled in the bone biopsy substudy, received at least one dose of investigational product, and had an evaluable biopsy. All values are median (Q1, Q3) unless otherwise specified.

BFR/BS = bone formation rate per unit of bone surface; Cn = cancellous; Ct = intracortical; Ec = endocortical; MAR = mineral apposition rate; MS/BS = ratio of mineralizing surface to bone surface; Ps = periosteal; Q1, Q3 = quartiles 1 and 3; QM = once monthly.

^{^a}

n = number of biopsies with measurements at both baseline and month 2.

^{^b}

Measurements on the first set of double labeling performed at baseline before treatment. ^cthe Wilcoxon signed rank test.

^{^d}

With and ^ewithout imputation when only single labels were identified.