The effect of alfacalcidol and plain vitamin d on osteoporosis: A randomised controlled trial

Abstract

Background: Osteoporosis is " a systemic metabolic bone disease characterized by low bone mass and micro architectural deterioration with a consequent increase in bone fragility with susceptibility to fracture. Multiple drug therapy with Alendronate, Calcium & plain vitamin D or alfacalcidol has been established to treat osteoporosis. In any patient with healthy liver and kidneys, plain vitamin D is expected to be as good as more active form of vitamin D. This study was conducted to compare the efficacy, safety and cost effectiveness between alfacalcidol and plain vitamin D in addition to Calcium and Alendronate in the management of osteoporosis. Methods: The Randomized Controlled Trial was conducted in B.P. Koirala Institute of Health Sciences, a tertiary care hospital in Eastern Nepal, over a period of twelve months from January 2013 to December 2014. Patient in group A were given Alfacalcidol, and group B were given plain Vitamin D. Results: Most of the patients were from the age group 60-69 yrs of age; mean age 65.54 ± 7.49. The BMD and T score were recorded at baseline and after treatment. The BMD measured 0.62853±.060241 at baseline and 0.67910 ± 0.059040 after treatment and T score measured -3.204 ±0.5455 at baseline and -2.698 ± 0.5772 after treatment. There is no statistical significance between the parameters (BMD and T score) of the two groups. Conclusion: For the first time in Nepal we have shown that the therapy with alfacalcidol and plain vitamin D when used with alendronate and calcium, have similar efficacy and safety, though the cost of the treatment with alfacalcidol was much higher than that of the plain vitamin D group.