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Devogelaer J.-P.,Catholic University of Louvain | Sambrook P.,University of Sydney | Reid D.M.,University of Aberdeen | Goemaere S.,Universitair Ziekenhuis Gent | And 6 more authors.
Rheumatology (United Kingdom) | Year: 2013

Objective: Long-term glucocorticoid use is accompanied by rapid bone loss; however, early treatment with bisphosphonates prevents bone loss and reduces fracture risk. The aim of this study was to examine the effects of two bisphosphonates, i.v. zoledronic acid (ZOL) versus oral risedronate (RIS), on bone turnover markers (BTMs) in subjects with glucocorticoid-induced osteoporosis (GIO). Methods: Patients were randomly stratified according to the duration of pre-study glucocorticoid therapy [prevention subpopulation (ZOL, n = 144; RIS, n = 144) ≤3 months, treatment subpopulation (ZOL, n = 272; RIS, n = 273) >3 months]. Changes in β-C-terminal telopeptides of type 1 collagen (b-CTx), N-terminal telopeptide of type I collagen (NTx), procollagen type 1 N-terminal propeptide (P1NP) and bone-specific alkaline phosphatase (BSAP) from baseline were measured on day 10 and months 3, 6 and 12. Results: At most time points, there were significantly greater reductions (P<0.05) in the concentrations of serum β-CTx, P1NP and BSAP and urine NTx in subjects on ZOL compared with RIS in both males and females of the treatment and prevention subpopulations. In pre- and post-menopausal women, there were significantly greater reductions in the concentrations of BTMs with ZOL compared with RIS. At 12 months, ZOL had significantly greater reductions compared with RIS (P<0.05) for β-CTx, P1NP, BSAP and NTx levels, independent of glucocorticoid dose. Conclusions: Once-yearly i.v. infusion of ZOL 5mg was well tolerated in different subgroups of GIO patients. ZOL was non-inferior to RIS and even superior to RIS in the response of BTMs in GIO patients. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. Source


Ish-Shalom S.,Bone and Mineral Metabolism Unit | Dumitrache C.,Ci Parhon Institute Of Endocrinology | El-Husseini T.F.,Ain Shams University | Hussein A.,Ain Shams University | Barker C.,Lilly Research Laboratories UK
Current Medical Research and Opinion | Year: 2011

Objective: To observe and compare back pain and health-related quality of life (HRQoL) in postmenopausal women with a prior unsatisfactory response to antiresorptive therapy, treated with teriparatide (TPTD) or alternative treatments in normal clinical practice. Research design and methods: Prospective, observational, multicentre, 24-month study of postmenopausal women with osteoporosis. A back pain and HRQoL questionnaire (European Quality of Life Questionnaire, EQ-5D) including visual analogue scale (VAS) was completed at each visit. Results: A total of 153 patients were enrolled, 105 patients started TPTD treatment during the study (TPTD cohort) and 48 patients did not take TPTD treatment at any time during the study (non-TPTD cohort). Four patients did not meet the inclusion criteria for the study. Of the patients in the non-TPTD cohort, 31 (68.9) took antiresorptives during the study. The patients selected by the investigator for teriparatide treatment were distinctly different from those not selected. At baseline, the mean back pain VAS was greater in the TPTD than the non-TPTD cohort, 64mm and 42mm, respectively (p<0.001). During the study, compared with baseline, the mean back pain VAS decreased in the TPTD cohort at all visits (p<0.001). In the non-TPTD cohort, a transitory decrease in the mean after 12 months was observed (-10mm, p0.023) only. After 24 months, the mean back pain VAS improved in the TPTD cohort (-36mm, p<0.001) while no change was observed in the non-TPTD cohort (-4mm, p0.467). At baseline, the mean EQ-VAS was lower in the TPTD than in the non-TPTD cohort, 40.8 and 55.2, respectively (p<0.001). After 24 months, EQ-VAS improved in both cohorts (TPTD 34, p<0.001 and non-TPTD 9, p0.026). Conclusions: TPTD-treated patients had more back pain and lower HRQoL at baseline. In the TPTD cohort the mean value was consistently and significantly improved in back pain and quality of life. In the non-TPTD cohort, the mean improvement in back pain and QoL was inconsistent possibly due to the initially higher QoL and lower back pain leaving less room for improvement. These results should be interpreted in the context of limitations related to a non-randomised observational study. © 2011 Informa UK Ltd All rights reserved. Source


Ma Y.L.,Lilly Research Laboratories | Marin F.,Lilly Research Center | Stepan J.,Charles University | Ish-Shalom S.,Bone and Mineral Metabolism Unit | And 10 more authors.
Bone | Year: 2011

The periosteum contains osteogenic cells that regulate the outer shape of bone and contribute to determine its cortical thickness, size and position. We assessed the effects of subcutaneous injections of teriparatide (TPTD, 20μg/day) or oral strontium ranelate (SrR, 2g/day) in postmenopausal women with osteoporosis on new bone formation activity at the periosteal and endosteal bone surfaces using dynamic histomorphometric measurements. Evaluable tetracycline-labeled transiliac crest bone biopsies were analyzed from 27 patients in the TPTD group, and 22 in the SrR group after six months of treatment. Measurements were conducted on the thicker and thinner cortices separately, and comparisons between the thicker, thinner and combined cortices were carried out. At the combined periosteal cortex, the mineralization surface as a percent of bone surface (MS/BS%) was greater for TPTD (mean±SE: 8.08±1.22%) than SrR (3.22±1.05%) (p<0.005). The difference in mineral apposition rate (MAR) between TPTD (0.35±0.06μm/day) and SrR (0.14±0.06μm/day) was also significant (p<0.05), while that of bone formation rate per bone surface (BFR/BS) between TPTD (0.014plusmn;0.004 mm 3/mm 2/year) and SrR (0.004plusmn;0.003 mm 3/mm 2/year) was not (p=0.057). Statistically significant differences between the two treatments were also observed for MS/BS%, BFR/BS, MAR and the double-labeled perimeter in the periosteum of the thicker, but not thinner, iliac crest cortices. The comparison between the thicker and thinner cortices of both periosteal and endosteal surfaces showed statistically significant differences for MAR and the double-labeled perimeter for TPTD treated women. There were no statistically significant differences in any bone formation dynamic measurements between the two cortices in the SrR group.In conclusion, most of the bone formation and mineralization variables were significantly higher for TPTD- than SrR-treated women at both the periosteal and endosteal combined cortices. The response to TPTD for dynamic bone formation measurements in the periosteal surface was greater for the thicker than thinner cortex, but this difference was not significant in SrR treated patients. This may reflect a greater ability of TPTD to enhance responsiveness of bone to the mechanical loading environment. These effects on bone formation may underlie the improvement in bone quality in patients with osteoporosis treated with TPTD. © 2011 Elsevier Inc. Source


Tepper S.,Ben - Gurion University of the Negev | Shahar D.R.,Ben - Gurion University of the Negev | Geva D.,Ben - Gurion University of the Negev | Ish-Shalom S.,Bone and Mineral Metabolism Unit
Journal of Steroid Biochemistry and Molecular Biology | Year: 2014

Vitamin D replenishment therapy typically entails standard dosages, but related increases in serum 25(OH)D levels vary between individuals. This study was aimed to identify factors that affect the efficacy of vitamin D supplementation. Subjects and methods 79 healthy men aged 25-65 with 25(OH)D < 20 ng/ml participated in a vitamin D supplementation study. All participants received 100,000 IU vitamin D bimonthly, e.g., 1666 IU/day. Personal and demographic information, physical activity and sun-exposure questionnaires were completed by the participants. Weight, height, and waist circumference were recorded. Serum calcium, creatinine, 25(OH)D, PTH, lipid profile, and liver-enzyme levels were assessed. All measurements were repeated after 6 and 12 months. The difference between baseline serum 25(OH)D and 12-month measurements was calculated (delta). Linear regression was performed to identify predictors for increases in 25(OH)D levels. Results Mean serum 25(OH)D level increases according to BMI were 12.6 ± 5.29 ng/ml for BMI ≠25, 10.12 ± 4.95 ng/ml for 25 < BMI 30, and only 6.39 ;plusmn 5.33 ng/ml for BMI 30, which differed significantly from the other BMI categories (p = 0.003). In a regression model to predict 25(OH)D increase, BMI was the main predictor (p ;< 0.001), explaining 21.6% of the variance in serum 25(OH)D (inverse association). Age, sun-exposure, serum cholesterol, physical-activity, baseline 25(OH)D levels and seasonality were insignificant. The full model explained 27.9% of the variance in serum 25(OH)D. Conclusion This study's main findings are that BMI affect vitamin D response in healthy men. Quantitative supplementation adjustments may be warranted in obese men, for whom the dose may need to be doubled. This article is part of a special issue entitled '16th Vitamin D Workshop'.© 2013 Elsevier Ltd. Source


Souberbielle J.-C.,Laboratoire Of Physiologie | Body J.-J.,Free University of Colombia | Lappe J.M.,Creighton University | Plebani M.,University of Padua | And 19 more authors.
Autoimmunity Reviews | Year: 2010

Background: There is increasing evidence that, in addition to the well-known effects on musculoskeletal health, vitamin D status may be related to a number of non-skeletal diseases. An international expert panel formulated recommendations on vitamin D for clinical practice, taking into consideration the best evidence available based on published literature today. In addition, where data were limited to smaller clinical trials or epidemiologic studies, the panel made expert-opinion based recommendations. Methods: Twenty-five experts from various disciplines (classical clinical applications, cardiology, autoimmunity, and cancer) established draft recommendations during a 2-day meeting. Thereafter, representatives of all disciplines refined the recommendations and related texts, subsequently reviewed by all panelists. For all recommendations, panelists expressed the extent of agreement using a 5-point scale. Results and conclusion: Recommendations were restricted to clinical practice and concern adult patients with or at risk for fractures, falls, cardiovascular or autoimmune diseases, and cancer. The panel reached substantial agreement about the need for vitamin D supplementation in specific groups of patients in these clinical areas and the need for assessing their 25-hydroxyvitamin D (25(OH)D) serum levels for optimal clinical care.A target range of at least 30 to 40ng/mL was recommended. As response to treatment varies by environmental factors and starting levels of 25(OH)D, testing may be warranted after at least 3months of supplementation. An assay measuring both 25(OH)D2 and 25(OH)D3 is recommended. Dark-skinned or veiled individuals not exposed much to the sun, elderly and institutionalized individuals may be supplemented (800IU/day) without baseline testing. © 2010 Elsevier B.V. Source

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