Potency of a combined alfacalcidol-alendronate therapy to reduce the risk of falls and fractures in elderly patients with glucocorticoid-induced osteoporosis.

This is a preplanned subgroup analysis on 318 patients with glucocorticoid-induced osteoporosis (GIOP) from an open, prospective, multi-centered, uncontrolled study on a large cohort of elderly patients with a high risk of falls and fractures. The entire group of 2579 patients was recruited by 818 practicing physicians and treated for three months with a new combination package containing 4 or 12 self-explanatory one-week blisters, each with one tablet of 70 mg alendronate (CAS 260055-05-8) and 7 capsules of 1 pg alfacalcidol (CAS 41294-56-8) (Tevabone"). The average age of the GIOP patients was 71 years and the mean body mass index 26.

Risk reduction of falls and fractures, reduction of back pain and safety in elderly high risk patients receiving combined therapy with alfacalcidol and alendronate: a prospective study.

Efficacy and safety of a new combination package containing 4 or 12 self-explanatory one-week blisters, each with one tablet of 70 mg alendronate (CAS 260055-05-8) and 7 capsules of 1 microg alfacalcidol (CAS 41294-56-8) (Tevabone) on muscle power, muscle function, balance and back pain was investigated in an open, multi-centered, uncontrolled, prospective study on a cohort of elderly patients with a high risk of falls and fractures. 818 practicing physicians all over Germany recruited 2579 patients for a 3-month observational trial being treated with the above combination package. 92.

Effect of a six-month therapy with alfacalcidol on muscle power and balance and the number of fallers and falls.

Purpose: In an open observational prospective multicentered study on a cohort of patients with a creatinine clearance of < or = 65 ml/min and diagnosed with the "Esslinger Fall Risk Assessment" to be at an increased risk for falls the effect of daily treatment with 1 microg alfacalcidol (CAS 41294-56-8; Alpha-D3) on muscle power, balance and number of fallers and falls was investigated.

Methods: In this open prospective study on 237 participants recruited in Germany, 16.9% men and 83.

Differential effects of D-hormone analogs and native vitamin D on the risk of falls: a comparative meta-analysis.

The aim of this meta-analysis was to compare the antifall efficacy of native vitamin D to that of its hydroxylated analogs alfacalcidol and calcitriol. Randomized clinical trials comparing oral native vitamin D and its analogs alfacalcidol and calcitriol to a placebo were included. Sources included the Cochrane Controlled Trials Register, EMBASE, MEDLINE, a hand search of abstracts, as well as reference lists.

Low creatinine clearance, glucocorticoid treatment, rheumatoid arthritis--different etiologies for low D-hormone syndrome and its associated increased risk for falls.

Low D-hormone syndrome, a disorder related to low creatinine clearance (CrCl), is associated with a roughly 4-fold increase in risk for falls. Known conditions leading to low D-hormone syndrome are CrCl < 65 ml/min, drug interactions, and chronic inflammatory diseases. This article reviews recent studies showing that treatment with D-hormone analogs, such as alfacalcidol, can reduce the frequency of falls in patients with low D-hormone syndrome.

Alfacalcidol versus plain vitamin D in the treatment of glucocorticoid/inflammation-induced osteoporosis.

Treatment with plain vitamin D is a nutritional substitute, while the application of alfacalcidol is an active hormonal therapy. Due to strong feedback regulation, plain vitamin D is not activated in the kidney in vitamin-replete patients, while alfacalcidol, having been hydroxylated at position 1, bypasses regulation and increases available amounts of active D-hormone in different target tissues. Nevertheless, a majority of physicians still prescribe plain vitamin D plus calcium as a first-step prevention or even as therapy for glucocorticoid (GC) induced osteoporosis.

Alfacalcidol versus plain vitamin D in inflammation induced bone loss.

Inflammatory diseases lead to systemic osteoporosis. Causal factors include increased circulating concentrations of inflammatory cytokines such as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), glucocorticoid medication, and reduced physical activity. In addition, disturbances of vitamin D metabolism play an important role for the development of inflammation induced osteoporosis.

The D-hormone analog alfacalcidol: the pioneer beyond the horizon of osteoporosis treatment.

Over the last 30 years, several clinical trials have reported the efficacy of D-hormone analogs to treat primary and secondary osteoporosis, and their genomic and nongenomic mode of action have been demonstrated with the progress of biochemical research technologies. Recent metaanalyses reviewed the preventive effect on falls and fractures of "vitamin D3" in the elderly population, mainly based on studies with alfacalcidol and calcitriol. In future a clear differentiation must be made between calcium and plain vitamin D supplementation in very old, vitamin D-deficient women and men (> 75 years) and the pharmacological treatment of patients with established osteoporosis using D-hormone analogs, independent of a patient's vitamin D status.

In elderly men and women treated for osteoporosis a low creatinine clearance of <65 ml/min is a risk factor for falls and fractures.

Recently, a low creatinine clearance (CrCl) of < 65 ml/min was described as a new significant and independent risk factor for the number of fallers and falls in a community-dwelling elderly population. In this study we investigated if a low creatinine clearance of < 65 ml/min is also a risk factor for falls and fractures in elderly men and women treated for osteoporosis. In a cross-sectional study with the help of questionnaires we assessed the prevalence of having experienced falls within the last 12 months according to renal function in 5,313 German men and women receiving treatment for osteoporosis.

A new significant and independent risk factor for falls in elderly men and women: a low creatinine clearance of less than 65 ml/min.

Objectives: Because impaired renal function is detrimental for the conversion of calcidiol to calcitriol (D-hormone) and since D-hormone analogues have been shown to decrease the risk of falls, we investigated whether creatinine clearance (CrCl) is associated with the number of fallers and falls in elderly men and women.

Methods: Within a randomized controlled study, we observed for 36 weeks 186 placebo-treated community-dwelling elderly men and women over 70, in an attempt to determine the influence of baseline CrCl on calcitropic hormone serum levels, as well as the influence of baseline CrCl on the number of fallers and falls over time. With the help of questionnaires, we regularly assessed fall incidence and frequency.

Prevention and therapy of osteoporosis: the roles of plain vitamin D and alfacalcidol.

Severe vitamin D deficiency was identified only in the first decades of the last century as the most common aetiology of rickets in children and osteomalacia in adults. It was later shown that vitamin D is not, as had been supposed, the biologically active principle for healing bone disease but must be hydroxylated in the liver and then finally in the kidney to become 1alpha,25-dihydroxy-cholecalciferol, a biologically highly active renal hormone. This study reviews the various principles, mechanisms, and approaches to the treatment of different forms of osteoporosis using vitamin D, alfacalcidol, and calcitriol therapy regimens.

Treatment with alfacalcidol in elderly people significantly decreases the high risk of falls associated with a low creatinine clearance of <65 ml/min.

We previously observed that a creatinine clearance (CrCl) of <65 ml/min is a significant and independent risk factor for the number of fallers and falls in a community-dwelling elderly population and postulated that this increased risk is due to the associated significant lower D-hormone serum levels. To test our hypothesis, we investigated in a post hoc analysis of a double-blind randomized study whether treatment with alfacalcidol, a synthetic prodrug of the D-hormone, can reduce the high incidence of fallers and the high risk of falls associated with low CrCl. Of 378 Swiss community-dwelling women (n=191) and men (n=187), aged 70 years and older, 191 received randomly 1 microg capsules of alfacalcidol (AlphaD3: Teva), and 187 received one capsule of placebo daily.

Alfacalcidol reduces the number of fallers in a community-dwelling elderly population with a minimum calcium intake of more than 500 mg daily.

Objectives: To study the effect of alfacalcidol (1alpha(OH)D3) on fall risk in community-dwelling elderly men and women.

Design: Randomized, double-blind, placebo-controlled intervention trial.

Setting: Basel, Switzerland.