The effect of rectally administered steroids on bone turnover: a comparative study

Background:

Oral glucocorticoids contribute significantly to the risk of osteoporosis in patients with inflammatory bowel disease. Less well established are the effects of rectally administered steroids on bone metabolism.

Aim:

To investigate the effects of two widely used rectal foam preparations (prednisolone metasulphobenzoate and hydrocortisone acetate) on biochemical markers of bone turnover.

Methods:

Twenty-four patients with active inflammatory bowel disease randomly received a standard course of either prednisolone metasulphobenzoate or hydrocortisone acetate for 2 weeks. Biochemical markers of bone turnover were measured before, during and after treatment. Bone formation markers measured were serum osteocalcin (BGP) and bone-specific alkaline phosphatase (BALP). Urinary deoxypyridinoline (DPD) was measured to assess bone resorption.

Results:

Disease activity scores improved during treatment (difference in mean Powell–Tuck score = 3.4, 95% CI: 2.0–4.8, P < 0.0001) and were similar in both hydrocortisone and prednisolone-treated groups. There was no significant reduction in BALP or BGP during treatment with either steroid preparation, and urinary DPD did not change significantly during treatment.

Conclusions:

During a 2-week course of rectal hydrocortisone acetate or prednisolone metasulphobenzoate, there was no significant change in biochemical markers of bone formation or resorption. These results suggest that pharmacological doses of rectal steroid foam preparations do not significantly impair bone turnover in patients with inflammatory bowel disease.

     

Comment and Reply on:International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer

Abstract

Objective:

To determine the safety and efficacy of full-length parathyroid hormone, PTH(1–84), treatment for up to 36 months by evaluating bone mineral density (BMD) changes, bone histomorphometric indices, and clinical fracture incidence in postmenopausal women with osteoporosis.     

The effect of semelil (angipars?) on bone resorption and bone formation markers in type 2 diabetic patients

Background and purpose of the study

Diabetes mellitus has been recognized as a major risk factor for osteoporosis in which bone turnover is affected by different mechanisms. As the morbidity, mortality and financial cost related to osteoporosis are expected to rise in Iran in coming years, and considering the efficacy of Angipars® for improvement of different ulcers which made it a new herbal drug in diabetic foot ulcer, there is a need to evaluate the effect of this new drug on different organs including bone resorption and bone formation markers.

Methods

In this randomized, double- blind clinical trial, 61 diabetic patients were included. The subjects were randomly divided into intervention and control groups. Subjects of intervention group received 100 mg of Angipars® twice a day. Laboratory tests including bone resorption and bone formation markers were performed at baseline and after 3 months.

Result

31 patients in study group and 30 patients in control group finished the study. The mean age of the study population and the mean disease duration was respectively 51.8 ± 6.2 and 7.5 ± 4.7 years with no significant differences between intervention and control patients. No statistically significant differences between patients and controls were observed in pyridinoline, osteocalcin, urine calcium, bone alkaline phosphatase and tumor necrosis factor (TNF-α). Only urine creatinine level significantly changed between two groups after 3 month of treatment (p-value: 0.029)

Conclusion

In conclusion, the findings of this study indicate that Semelil (Angipars®) had no beneficial or harmful effects on bone. It might be other effects of this new component on bone turnover process which need more studies and more time to be discovered.     

Increased bone resorption in patients with Crohn's disease

Background:

Patients with Crohn’s disease are at risk of osteoporosis and premature fracture. However, the pathophysiology underlying bone loss remains poorly understood and the optimum treatment has not been established.

Aim:

To investigate mechanisms of bone loss in Crohn’s disease using biochemical markers of bone turnover.

Methods:

Bone mineral density was measured at the hip and spine using dual-energy X-ray absorptiometry in 117 patients (48 male) with Crohn’s disease. Bone turnover was assessed by measuring serum osteocalcin (BGP), pro-collagen carboxy-terminal propeptide (PICP), bone specific alkaline phosphatase (BALP) and urinary deoxypyridinoline (DPD); and compared to age-matched healthy controls (n = 28).

Results:

Bone mineral density was reduced (z-score < ?1) in 48 (41%) patients with Crohn’s disease. Mean values for bone formation markers in patients with Crohn’s disease were all within the normal reference range (BGP 8.92 (± 3.23) ng/mL (normal range 3.4–10.0), BALP 17.6 (± 12.6) U/L (normal range 11.6–43.3), PICP 95.1 (± 46.5) ng/mL (normal range 69–163)) and were not significantly different to the control population. However, mean urinary DPD was significantly higher in patients with Crohn’s disease compared to healthy controls (10.97 (± 9.22) n M DPD/m M creatinine vs. 5.02 (± 1.03) n M DPD/m M creatinine, difference in means = 5.95, 95% CI: ?9.6 to ?2.3, P = 0.00001) and compared to the UK reference range DPD levels were increased in 74 (63%) patients.

Conclusions:

Bone resorption as evidenced by urinary DPD was frequently increased in patients with Crohn’s disease and was significantly higher than in an age-matched control population. The high levels of urinary DPD suggest increased bone collagen degradation may contribute to osteoporosis in patients with Crohn’s disease. These results suggest anti-resorptive agents such as the bisphosphonates may be effective treatment for osteoporosis in Crohn’s disease.

     

Efficacy and safety of bazedoxifene,a novel selective estrogen receptor modulator for the prevention and treatment of postmenopausal osteoporosis

Abstract

Objective:

Osteoporosis affects millions of individuals, particularly postmenopausal women, and imposes a severe burden on patients and the healthcare system. Several therapeutic options are commercially available for the prevention and treatment of osteoporosis, including bisphosphonates, hormone therapy, and the selective estrogen receptor modulator (SERM), raloxifene. Because each of these agents has its own individual risk-benefit profile, their use should be tailored to specific patient populations. While many agents are approved for osteoporosis, new therapies are needed that maximize efficacy outcomes and minimize safety concerns. Several new SERMs are being evaluated in an effort to achieve an ideal tissue selectivity profile, with beneficial effects on bone without negative effects on the endometrium and breast. Bazedoxifene is a novel SERM that was recently approved in the European Union and is undergoing regulatory review in the United States for the prevention and treatment of postmenopausal osteoporosis. This article reviews the clinical efficacy and safety data for bazedoxifene in postmenopausal women with or at risk for osteoporosis.     

Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels

Abstract Background: Three-year treatment with eldecalcitol has been shown to improve lumbar and total hip bone mineral density (BMD), decrease bone turnover markers, and lower the incidences of vertebral and wrist fractures in patients with osteoporosis more than with treatment with alfacalcidol under vitamin D repletion. The purpose of this study was to determine whether there was a risk of eldecalcitol causing severely suppressed bone turnover in osteoporosis patients with low pre-treatment levels of bone turnover markers. Methods and results: Post-hoc analysis was conducted on the data from a 3-year, randomized, double-blind, active-comparator, clinical trial of eldecalcitol versus alfacalcidol under vitamin D repletion conducted in Japan. Enrolled patients with baseline measurements of bone turnover markers were stratified into tertiles according to their pre-treatment levels of serum bone-specific alkaline phosphatase, serum procollagen type I N-terminal propeptide, or urinary collagen-N-telopeptide. Eldecalcitol treatment rapidly reduced bone turnover markers, and kept them within the normal range. However, in the patients whose baseline values for bone turnover were low, eldecalcitol treatment did not further reduce bone turnover markers during the 3-year treatment period. Further long-term observation may be required to reach the conclusion. ClinicalTrials.gov number: NCT00144456. Conclusions: Eldecalcitol normalizes, but does not overly suppress, bone turnover regardless of baseline levels of bone turnover markers. Thus, it is unlikely that eldecalcitol treatment will increase the risk of severely suppressed bone turnover and therefore deterioration of bone quality, at least for a treatment duration of 3 years.     

Vertebral fracture risk after once-weekly teriparatide injections: follow-up study of Teriparatide Once-Weekly Efficacy Research (TOWER) trial

Abstract

Objective:

To evaluate fracture risk and bone mineral density (BMD) in patients with primary osteoporosis, 1 year after completing 72 weeks of weekly teriparatide injections.     

Long-term outcomes of children and adolescents who had cerebral palsy with secondary osteoporosis

Abstract

Objective:

To investigate the long-term efficacy and index of treatment with vitamin D alone or with a bisphosphonate in children and adolescents who have cerebral palsy (CP) with secondary osteoporosis.     

Evaluation of the clinical benefit of long-term (beyond 2 years) treatment of skeletal-related events in advanced cancers with zoledronic acid

Abstract

Background:

Skeletal complications of malignant bone disease are common among patients with both solid tumors and multiple myeloma (MM). Zoledronic acid (ZOL; Zometa) is an intravenous bisphosphonate with proven efficacy in reducing the incidence of skeletal complications and delaying the time to a first skeletal complication. This study was designed to assess the continued benefit of ZOL treatment over a prolonged period.     

Vitamin D supplementation in elderly or postmenopausal women: a 2013 update of the 2008 recommendations from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)

Abstract

Background:

Vitamin D insufficiency has deleterious consequences on health outcomes. In elderly or postmenopausal women, it may exacerbate osteoporosis.     

Sex hormone status and bone metabolism in men with Crohn's disease

Background:

Men with Crohn’s disease (CD) are at risk of osteoporosis, but the factors contributing to low bone mineral density and its optimum treatment have not been established.

Aim:

To investigate the sex hormone status of men with CD, and to establish the influence of sex hormones on their bone metabolism.

Methods:

Bone density was measured by dual energy X-ray absorptiometry at the hip and lumbar spine in 48 men with CD. Total serum testosterone and gonadotrophins were measured in all subjects and the free androgen index calculated in men with low or borderline total testosterone. Serum osteocalcin, pro-collagen carboxy-terminal peptide, bone specific alkaline phosphatase and urinary deoxypyridinoline were measured as markers of bone turnover.

Results:

Eight (17%) men had osteoporosis, and a further 14 (29%) had osteopenia. Three (6%) men had a low free androgen index and normal gonadotrophins consistent with secondary hypogonadism, two of whom had osteopenia of the hip and spine. Age (P=0.002) and small bowel Crohn’s disease (P=0.02) were the only independent predictors of serum testosterone. There was a significant association between total testosterone and osteocalcin (r=0.53, 95% CI: 0.29–0.71, P=0.0001) which was independent of age and current steroid use (P=0.0001).

Conclusions:

Previously undiagnosed hypogonadism is an uncommon cause of low bone density in men with CD. The independent association between testosterone and the bone formation marker osteocalcin suggests sex hormone status influences bone metabolism in men with CD. The results suggest testosterone replacement might be effective treatment for some men with osteoporosis and Crohn’s disease.

     

Changing trends in osteoporosis care from specialty to primary care physicians

Abstract

Background:

Inadequate treatment by non-specialty primary care physicians (PCPs) has been a concern in improving osteoporosis care. An increase in outpatient visits by older patients seeking osteoporosis care has been reported. But what percentages of these visits are made to PCPs are unknown. We investigated recent trends of outpatient visits and treatment for osteoporosis in older adults (>50 years) by physician type (PCPs vs. specialty care non-PCPs).     

The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data

Aim:

Oral risedronate is effective in the treatment of postmenopausal osteoporosis when administered daily, weekly, or monthly. In this 1-year, randomized, double-blind, multicenter study we compared the weekly 35-mg and daily 5-mg risedronate dosing regimens in the treatment of Chinese postmenopausal women with osteoporosis or osteopenia.

Methods:

Postmenopausal women with primary osteoporosis or osteopenia were randomly assigned to the weekly group or daily group (n=145 for each) that received oral risedronate 35 mg once a week or 5 mg daily, respectively, for 1 year. The subjects'' bone mineral densities (BMDs), bone turnover markers (P1NP and β-CTX), new vertebral fractures, and adverse events were assessed at baseline and during the treatments.

Results:

All subjects in the weekly group and 144 subjects in the daily group completed the study. The primary efficacy endpoint after 1 year, ie the mean percent changes in the lumbar spine BMD (95% CI) were 4.87% (3.92% to 5.81%) for the weekly group and 4.35% (3.31% to 5.39%) for the daily group. The incidences of clinical adverse events were 48.3% in the weekly group and 54.2% in the daily group.

Conclusion:

The weekly 35-mg and daily 5-mg risedronate dosing regimens during 1 year of follow-up show similar efficacy in improving BMDs and biochemical markers of bone turnover in Chinese postmenopausal women with osteoporosis or osteopenia. Moreover, the two dosing regimens exhibit similar safety and tolerability.     

Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised,double-blind,placebo-controlled trial

Abstract

Objective:

The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trials report that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describe the rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.     

Adherence and persistence in patients with severe osteoporosis treated with teriparatide

Abstract

Introduction:

Medical intervention plays a key role in the treatment of postmenopausal osteoporosis and patients’ adherence to therapy is essential for optimal clinical outcomes. While adherence in RCTs is usually around 70–90%, a previous study showed that in clinical practice only 27.8% and 46.5% of the women on oral daily vs. weekly alendronate were still on treatment after 12 months. Data on adherence to teriparatide (TPTD) treatment of severe postmenopausal osteoporosis are available from only few countries. This study assessed adherence and persistence with TPTD in Germany.     

Long-term treatment of osteoporosis in postmenopausal women: a review from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Osteoporosis Foundation (IOF)

Abstract

Introduction:

Postmenopausal osteoporosis is a chronic disease requiring treatment that balances long-term fracture efficacy against risk.     

Sustained vertebral antifracture efficacy of oral anti-osteoporotic therapies in postmenopausal osteoporosis

Abstract

Objective:

Vertebral fractures are common in women with postmenopausal osteoporosis, a chronic condition requiring long-term treatment with anti-osteoporotic treatments. Therefore, it is important to assess sustainability of antifracture efficacy.     

Long-term raloxifene for postmenopausal osteoporosis

Abstract

Background:

Due to the chronic nature of osteoporosis and the risk of invasive breast cancer, raloxifene 60?mg/day (raloxifene) is intended to be used for long-term treatment (treatment >3 years).     

Patient experience with a new teriparatide delivery device

Abstract

Objective:

To determine functionality and acceptability of a new teriparatide (Forteo, Eli Lilly and Company, Indianapolis, IN, USA) delivery device by patients with osteoporosis.     

Alendronate in patients with calcium nephrolithiasis and loss of bone mass

Background

Our purpose is to show the effect of alendronate on patients with recurrent calcium lithiasis and loss of bone mass, and to observe their progress with analytical and densitometric markers.

Methods

We present a unique cohort (before and after study) of 15 patients with recurrent calcium nephrolithiasis and loss of bone mass treated for three years with 70 mg sodium alendronate weekly. The sample is divided into two groups by sex (5 men and 10 women, aged 35–65 years). We assessed clinical progress of both bone and lithiasic disease and urine and plasma markers of both pathologies.

Results

We obtained a significant decrease in calcuria levels after 3 years of treatment (15.1 vs. 10.1; p=0.01), fasting calcium/creatinine quotient (0.16 vs. 0.10; p=0.002), and β-crosslaps (0.596 vs. 0.501; p=0.01). Moreover, we observed a disease stabilization in 14 of the 15 patients (93.3%), and, in all patients, bone mineral density had improved. Neither side effects nor losses of patients were observed after 3 years of treatment.

Conclusions

The use of weekly alendronate in patients with recurrent calcium lithiasis and loss of bone mass is safe and effective, curbs lithiasic disease progression, and improves bone mineral density.