Key result
Combined therapy with risedronate and vitamin K2 did not demonstrate any additional effects on bone metabolic markers compared to risedronate monotherapy in corticosteroid-treated patients.
Why the study?
Does combined risedronate and vitamin K2 therapy improve bone metabolic markers compared to risedronate monotherapy in corticosteroid-treated patients?
RCT (n=22)
Open-label
Randomly assigned
No
Does combined risedronate and vitamin K2 therapy improve bone metabolic markers compared to risedronate monotherapy in corticosteroid-treated patients?
Vitamin K2 supplementation provides no additional effect on bone metabolic markers when added to risedronate in corticosteroid-treated patients, and ucOC is not a reliable indicator of vitamin K status in this population.
Answers are grounded in this paper and cite their sources.
No benefit to adding vitamin K2 to risedronate; confirms monotherapy suffices for bone markers in this RCT.
OBJECTIVE: The aim of this study was to investigate the responses of serum osteocalcin (OC), undercarboxylated osteocalcin (ucOC) and N-terminal telopeptide of type I collagen (NTx) to corticosteroids, and to examine the effects of risedronate therapy with or without vitamin K(2) supplementation on bone metabolic markers in corticosteroid-treated patients. METHODS: Sixteen patients on corticosteroid therapy for neuromuscular disorders were assigned randomly to 2 groups (A: risedronate monotherapy, n=8; B: combined risedronate and vitamin K(2) therapy, n=8) and treated for 1 year. Another 6 patients who received intravenous steroid pulse therapy were assigned to group C for investigation of the effects of corticosteroids on OC and ucOC 1 month after pulse therapy. RESULTS: Serial measurements revealed that significant decreases of OC, ucOC and NTx persisted with a similar time course profile during 1 year of treatment in groups A and B, and between-group analysis failed to demonstrate any additional effects of vitamin K(2) on risedronate therapy. Intravenous steroid pulse therapy induced a transient depression of OC and ucOC within 1 week in group C. CONCLUSION: These results indicate that serum concentrations of OC and ucOC become consistently low during corticosteroid administration despite risedronate therapy with or without vitamin K(2) supplementation, and the serum ucOC level may not be a reliable indicator of vitamin K status under corticosteroid administration.
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Hozuki et al. (2010) conducted an RCT in Corticosteroid-induced osteoporosis in neuromuscular disorders (n=22). Combined risedronate and vitamin K2 (menatetrenone) vs. Risedronate monotherapy (2.5 mg/day) was evaluated on Percent change in serum osteocalcin (OC) at 12 months (p=>0.05). Combined therapy with risedronate and vitamin K2 did not demonstrate any additional effects on bone metabolic markers compared to risedronate monotherapy in corticosteroid-treated patients.
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