Minodronate for the treatment of osteoporosis

Figures & data

Table 1 Clinical studies on minodronate in the treatment of osteoporosis with an observation period of ≥12 months

Study	Drugs and patients	Age (years)	FU	BMD	Bone markers	AEs
Hagino et al^Citation28	D-MIN (n=134) D-ALN (n=135)	63.9±6.6 65.8±6.9	12 M	MIN: LS, +5.9%; TH, +3.5% ALN: LS, +6.3%; TH, +3.3%	uDPD and uNTX decreased in MIN more than in ALN	No difference between groups
Matsumoto et al^Citation29	D-MIN (n=343) PLC (n=331)	71.4±6.0 71.7±5.6	24 M	N/A	uNTX, uDPD, BAP, and OC decreased in MIN more than in PLC	Similar in both groups
Ito et al^Citation57	D-MIN (n=103)	63.9±6.4	12 M	Increased for FN, IT, and femoral shaft	N/A	N/A
Okazaki et al^Citation30	D-MIN (n=234) M-MIN 30 mg (n=229) M-MIN 50 mg (n=229)	51–89 years older women and men	12 M	M-MIN (30 and 50 mg): noninferiority to D-MIN for LS and TH	No difference among groups for decrease of uNTX, uDPD, BAP, and BGP	Similar among groups
Hagino et al^Citation31	D-MIN (n=64) PLC/D-MIN (n=61)	71.1±0.4 (SE) 71.4±0.4 (SE)	36 M	LS: MIN: +10.4% PLC/MIN: +6.1%	uDPD, uNTX, BAP, and OC decreased by 30%–60% in MIN	Similar in both groups
Iwamoto et al^Citation42	M-MIN (n=42)	71.8±7.3	12 M	N/A	uNTX decreased	No serious AEs
Ebina et al^Citation33	M-MIN (n=53) M-MIN + VK (n=42) M-MIN + ELD (n=65)	71.7±1.6 71.7±1.0 71.8±0.9	12 M	More increase in MIN + ELD than in other groups for LS, TH, and FN	TRACP-5b, P1NP, and ucOC decreased in MIN + ELD more than in the other groups	N/A
Ebina et al^Citation36	a. W-ALN or W-RIS continue (n=88) b. M-MIN (n=44) switch from W-ALN c. M-MIN (n=40) switch from W-RIS	a. 64.9±0.9 (SE) b. 64.9±1.6 (SE) c. 67.3±1.6 (SE)	12 M	More increase in the switch group than in the continue group for LS, TH, and FN	TRACP-5b, P1NP, and ucOC decreased in the switch group than in the continue group	N/A
Miyaoka et al^Citation58	M-MIN (n=26) switch from TPTD	64.9±11.8	12 M	Maintained LS	uNTX decreased	N/A
Nakatoh^Citation40	M-MIN (n=41) RLX (n=42) ELD (n=38) switch from TPTD	81.6±5.0 82.7±5.5 83.0±5.4	12 M	LS and TH in MIN were increased	BAP and TRACT-5b decreased in all groups	N/A
Toda et al^Citation39	M-MIN (n=25) switch from RLX	66 (36–77)	24 M	LS: +6.7% FN: +3.9%	BAP decreased by 30% at 6 M	N/A
Ohishi et al^Citation38	M-MIN: a. Naïve (n=52) b. Switch from ALN or RIS (n=47)	a. 73.3±8.8 b. 75.9±9.5	27 M	Naïve: LS +9.1, FN +3.2, TH +3.1% Switch: LS +3.7% FN, TH: no change	P1NP and uNTX decreased by 50%–70% in naïve	N/A

Notes: Patients were all postmenopausal women if not otherwise indicated. Age is indicated by mean ± standard deviation if not otherwise indicated.

Abbreviations: AE, adverse event; BAP, bone-specific alkaline phosphatase; BGP, bone Gla protein; BMD, bone mineral density; D-ALN, 5 mg of daily alendronate; D-MIN, 1 mg of daily minodronate; ELD, eldecalcitol; FN, femoral neck; FU, follow-up period; IT, intertrochanter; LS, lumbar spine; M, months; M-MIN, 50 mg of monthly minodronate; N/A, not analyzed; OC, osteocalcin; PLC, placebo; P1NP, type I collagen N-terminal propeptide; RLX, raloxifene; SE, standard error; TH, total hip; TPTD, 20 μg of daily teriparatide; TRACP-5b, tartrate-resistant acid phosphatase-5b; ucOC, undercarboxylated osteocalcin; uDPD, urinary deoxypyridinoline; uNTX, urinary N-terminal telopeptide of type I collagen; VK, vitamin K₂; W-ALN, 35 mg of weekly alendronate; W-RIS, 35 mg of weekly risedronate.

Table 2 Comparisons of lumbar BMD change and vertebral fracture risk reduction among bisphosphonates over 2–3 years

BP	Study	Age (years)	Patients	n	FU (years)	Lumbar spine BMD change	RR for VF
Minodronate 1 mg daily	Matsumoto et al^Citation29	55–80	Women with 1–5 VF and BMD <80% YAM of lumbar spine	MIN 359 PLC 345	2	N/A	59%
	Hagino et al^Citation28			MIN 226 PLC/MINa 218	3	+10.4% +6.1%	42%
Alendronate 5 or 10 mg daily	Liberman et al^Citation85	45–80	Women with BMD <2.5 SD YAM of lumbar spine	ALN 526 PLC 355	3	+8.8% greater than PLC	48%
	Black et al^Citation12,Citation14	55–80	Women with existing VF	ALN 1,022 PLC 1,005	3	+6.2% greater than PLC	54%
			Women without VF and a T-score <−2.5 of femoral neck BMD	ALN 819 PLC 812	3	N/A	16%
Risedronate 2.5 or 5 mg daily	Harris et al^Citation13	<85	Women with ≥2 VF and a T-score <−2 of lumbar spine BMD	RIS 678 PLC 696	3	+5.4% +1.1%	41%
	Reginster et al^Citation86	≤85	Women with at least 2 VFs	RIS 346 PLC 344	3	+5.9% greater than PLC	49%
Zoledronate 5 mg yearly	Black et al^Citation59	65–89	Women with a T-score ≤−2.5 of femoral neck or ≤1.5 with VF	ZOL 3,861 PLC 3,875	3	+6.7% greater than PLC	70%

Note:

a Patients in PLC group were administered daily minodronate for 2 years.

Abbreviations: ALN, alendronate; BMD, bone mineral density; BP, bisphosphonate; FU, follow-up period; MIN, minodronate; N/A, not analyzed; PLC, placebo; RIS, risedronate; RR, relative risk reduction rate; VF, vertebral fracture; YAM, young adult mean; ZOL, zoledronate.

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