Background Osteoporosis is the most common metabolic bone disease. It affects a significant number of postmenopausal women and elderly people. Standard treatment of osteoporosis is the use of oral calcium and vitamin D in combination with one of the following drugs: bisphosphonates, raloxifene, parathyroid hormone, calcitonin, denosumab and strontium ralenate 1. Numerous studies have investigated the effects of vitamin K in bone health. These studies have shown conflicting results 2. There isn't any human study about adding of vitamin k to alendronate to treat osteoporosis.
Objectives The purpose of the present study was to compare the vitamin K and alenddronte versus alendronate alon on the bone mineral denity in postmenopausal osteoporosis.
Methods Forty - seven patients were introduced to the study from our Rheumatology Clinics. All patients had postmenopausal osteoporosis (T≤ -2.5). The patients were randomly assigned into two groups: one group (n=23) received calcium pills (500 mg twice daily), vitamin D pills (400 IU daily) and alendronate pills (70 mg weekly). The other group (n=24) received the same combination plus vitamin K1 pills (10 mg daily). The duration of treatment was one year in both groups. At the enrollment and the end of the study, bone mineral density was measure for all patients by the same scanner. Data were analyzed using SPSS software.
Results There was no significant difference in the baseline characteristics between the two groups. In the Vitamin K+ Alendronate group, the mean bone mineral density (BMD) of femoral neck before and after the intervention was 0.56±0.08 mg/cm2, that the difference was not significant (P=0.93). The mean BMD of femoral neck in the alendronate group before and after treatment were 0.61±0.09 mg/cm2 and 0.58±0.09 mg/cm2, that the difference was not significant (P=0.93). There was no significant difference between two groups regarding to the mean change of BMD of femoral neck before and after treatment (P=0.31). In the Vitamin K+ Alendronate group, the mean BMD of lumbar spine before and after the intervention were 0.76±0.11 mg/cm2 and 0.76±0.12 mg/cm2 and there was not significant change. In the alendronate group, the mean BMD of lumbar spine before and after were 0.71±0.06 mg/cm2 and 0.76±0.04 mg/cm2, that the change was significant (P=0.009). There was also no significant difference between two groups regarding to the mean change of BMD of lumbar spine before and after treatment (P=0.24). There was not any osteoporotic fracture in two groups.
Conclusions Adding vitamin K pills (10 mg daily) to Alendronate, calcium and vitamin D regime had no more effect on the increasing of BMD in patients with postmenopausal osteoporosis.
Cosman F, de Beur SJ, LeBoff MS, et al. Erratum to: Clinician's guide to prevention and treatment of osteoporosis. Osteoporosis International. 2015;26(7):2045–2047. doi: 10.1007/s00198-015-3037-x.
Cockayne S, Adamson J, Lanham-New S, Shearer MJ, Gilbody S, Torgerson DJ. Vitamin K and the prevention of fractures: systematic review and meta-analysis of randomized controlled trials. Archives of Internal Medicine 2006; 166: 1256–1261.
Acknowledgement Our study was supported by a research grant from the Vice Chancellor for Research, Mashhad University of Medical Sciences.
Disclosure of Interest None declared