Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: A randomized, double-blind, placebo-controlled extension trial

Abstract

Objective To evaluate the continued efficacy and safety of alendronate (ALN) for up to 2 years in patients receiving glucocorticoids. Methods This is a 12‐month extension of a previously completed 1‐year trial of daily ALN, performed to evaluate the effects of ALN over a total of 2 years in 66 men and 142 women continuing to receive at least 7.5 mg of prednisone or equivalent daily. All patients received supplemental calcium and vitamin D. The primary end point was the mean percentage change in lumbar spine bone mineral density (BMD) from baseline to 24 months. Other outcomes included changes in hip and total body BMD, biochemical markers of bone turnover, radiographic joint damage of the hands, and vertebral fracture incidence. Results The mean (±SEM) lumbar spine BMD increased by 2.8 ± 0.6%, 3.9 ± 0.7%, and 3.7 ± 0.6%, respectively, in the groups that received 5 mg, 10 mg, and 2.5/10 mg of ALN daily (P ≤ 0.001) and decreased by −0.8 ± 0.6% in the placebo group (P not significant) over 24 months. In patients receiving any dose of ALN, BMD was increased at the trochanter (P ≤ 0.05) and maintained at the femoral neck. Total body BMD was increased in patients receiving 5 or 10 mg ALN (P ≤ 0.01). These 2 dose levels of ALN were more effective than placebo at all sites (P ≤ 0.05). Bone turnover markers (N‐telopeptides of type I collagen and bone‐specific alkaline phosphatase) decreased 60% and 25%, respectively, during treatment with ALN (P ≤ 0.05). There were fewer patients with new vertebral fractures in the ALN group versus the placebo group (0.7% versus 6.8%; P = 0.026). The safety profile was similar between treatment groups. Conclusion Alendronate is an effective, well‐tolerated therapy for the prevention and treatment of glucocorticoid‐induced osteoporosis, with sustained treatment advantages for up to 2 years.

Prevention and treatment of glucocorticoid-induced osteoporosis with active vitamin D3 analogues: a review with meta-analysis of randomized controlled trials including organ transplantation studies

“…3). Так, в РКИ (плацебоконтролируемых или срав-нительных) получены доказательства высокого уровня по увеличению МПК поясничного отдела позвоночника и проксимального отдела бедра для алендроната [12,13], ризедроната [14,15], золедроновой кислоты [16] и терипа-ратида [17,18]. Однако уровень доказательности этих ис-следований ниже, чем при постменопаузальном ОП, по-скольку в качестве основного критерия эффективности в них изучалось не снижение риска переломов на фоне приема препаратов, а их влияние на МПК.…”

Glucocorticosteroid-induced spinal osteoporosis: scientific update on pathophysiology and treatment

“…These results were confirmed in the 12-month extension that included 208 of the initially enrolled patients. During this extension the incidence of new vertebral fractures was significantly reduced with alendronate versus placebo (6.8% placebo vs. 0.7% pooled alendronate, P<0.05) [2].…”

A Review of the 2008 Singapore Ministry of Health Clinical Practice Guidelines on Osteoporosis and an Update

“…Treatment options that were recommended by the CPG for glucocorticoid-induced osteoporosis included alendronate, risedronate and teriparatide all of which have been shown to prevent vertebral fractures in these patients [50][51][52] …”