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[Not Available].
Muheim, L
Praxis. 2017;(5):271-272
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Two-year outcomes on bone density and fracture incidence in patients with T2DM randomized to bariatric surgery versus intensive medical therapy.
Maghrabi, AH, Wolski, K, Abood, B, Licata, A, Pothier, C, Bhatt, DL, Nissen, S, Brethauer, SA, Kirwan, JP, Schauer, PR, et al
Obesity (Silver Spring, Md.). 2015;(12):2344-8
Abstract
OBJECTIVE To determine the 2-year outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) vs. intensive medical therapy (IMT) on lean body mass, total bone mass, and bone mineral density (BMD) measures from the STAMPEDE trial. METHODS 54 subjects (BMI: 36 ± 1 kg/m(2) , age: 48 ± 4 years) with type 2 diabetes (T2DM) (HbA1c : 9.7 ± 2%) were randomized to IMT, RYGB, or SG and underwent DXA at baseline and at 1 and 2 years. RESULTS At 2 years, the reduction in BMI was similar after RYGB and SG and was greater than IMT (P < 0.001). Lean mass was reduced by ∼10%, total bone mineral content reduced by ∼8%, and hip BMD reduced by ∼9% in both surgical groups and was significantly greater than IMT despite increases in vitamin D intake in all groups. The change in hip BMD correlated with weight loss (r = 0.84, P < 0.0001) and changes in lean mass (r = 0.74, P < 0.0001) and leptin (r = 0.53, P < 0.0001). Peripheral fractures were self-reported in RYGB (4/18 patients), SG (2/19 patients), and IMT (4/16 patients). CONCLUSIONS Surgically induced weight loss is associated with modest reductions in lean mass, bone mineral content, and BMD, despite calcium and vitamin D supplementation in patients with T2DM. Awareness for bone loss is indicated for patients undergoing bariatric procedures.
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Low bone mineral density and fragility fractures in permanent vegetative state patients.
Oppl, B, Michitsch, G, Misof, B, Kudlacek, S, Donis, J, Klaushofer, K, Zwerina, J, Zwettler, E
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2014;(5):1096-100
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Abstract
Disuse of the musculoskeletal system causes bone loss. Whether patients in vegetative state, a dramatic example of immobilization after severe brain injury, suffer from bone loss and fractures is currently unknown. Serum markers of bone turnover, bone mineral density (BMD) measurements, and clinical data were cross-sectionally analyzed in 30 consecutive vegetative state patients of a dedicated apallic care unit between 2003 and 2007 and compared with age- and sex-matched healthy individuals. Vegetative state patients showed low calcium levels and vitamin D deficiency compared with healthy controls. Serum bone turnover markers revealed high turnover as evidenced by markedly elevated carboxy-terminal telopeptide of type I collagen (β-crosslaps) and increased levels of alkaline phosphatase. BMD measured by dual-energy X-ray absorptiometry (DXA) scanning showed strongly decreased T- and Z-scores for hip and spine. Over a period of 5 years, 8 fragility fractures occurred at peripheral sites in 6 of 30 patients (n = 3 femur, n = 2 tibia, n = 2 fibula, n = 1 humerus). In conclusion, high bone turnover and low BMD is highly prevalent in vegetative state patients, translating into a clinically relevant problem as shown by fragility fractures in 20% of patients over a time period of 5 years. .
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Comparison of non-vertebral fracture between minodronate and risedronate therapy in elderly female patients with Alzheimer disease.
Sato, Y, Honda, Y, Iwamoto, J, Amano, N
Journal of musculoskeletal & neuronal interactions. 2013;(3):346-52
Abstract
OBJECTIVES Minodronate is a nitrogen-containing bisphosphonate that is commercially available for the treatment of osteoporosis in Japan. Preclinical studies demonstrated that minodronate is at least 10 times more potent than alendronate in inhibiting bone resorption in vivo. A high incidence of fractures, particularly of the hip, represents an important problem in Alzheimer disease (AD) patients who are prone to falls and may have osteoporosis. METHODS A total of 256 elderly patients with AD were assigned to daily treatment with 1.0 mg of minodronate or a daily treatment with risedronate combined with daily 1000 IU ergocalciferol and 1200 mg elemental calcium, and followed up for 12 months. RESULTS At baseline, patients of both groups showed low 25-hydroxyvitamin D with compensatory hyperparathyroidism. Non-vertebral fractures occurred in 5 patients in the minodronate group and 7 patients in the risedronate group (5 hip fractures; one fracture each at the distal forearm and pelvis). There was no difference in risk of hip fracture between the two groups (p=.70; odds ratio=0.8). CONCLUSIONS The study medications were well tolerated with relatively few adverse events and were equivalent in reducing the risk of a fracture in elderly patients with AD.
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Prevention of falls and fractures in old people by administration of calcium and vitamin D, randomized clinical trial.
López-Torres Hidalgo, J, ,
BMC public health. 2011;:910
Abstract
BACKGROUND There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons. The objective of this study is to determine the effectiveness of calcium and vitamin D supplementation in improving musculoskeletal function and decreasing the number of falls in person aged over 65 years. METHODS/DESIGN Phase III, randomized, double blind, placebo-controlled trial to evaluate the efficacy of already marketed drugs in a new indication. It will be performed at Primary Care doctor visits at several Healthcare Centers in different Spanish Health Areas. A total of 704 non-institutionalized subjects aged 65 years or older will be studied (sample size calculated for a statistical power of 80%, alpha error 0.05, annual incidence of falls 30% and expected reduction of 30% to 20% and expected loss to follow up of 20%). The test drug containing 800 IU of vitamin D and 1000 mg of calcium will be administered daily. The control group will receive a placebo. The subjects will be followed up over two years. The primary variable will be the incidence of spontaneous falls. The secondary variables will include: consequences of the falls (fractures, need for hospitalization), change in calcidiol plasma levels and other analytical determinations (transaminases, PTH, calcium/phosphorous, albumin, creatinine, etc.), change in bone mass by densitometry, change in muscle strength in the dominant hand and change in musculoskeletal strength, risk factors for falls, treatment compliance, adverse effects and socio-demographic data. DISCUSSION The following principles have been considered in the development of this Project: the product data are sufficient to ensure that the risks assumed by the study participants are acceptable, the study objectives will probably provide further knowledge on the problem studied and the available information justifies the performance of the study and its possible risk for the participants.If calcium and vitamin D supplementation is effective in the prevention of falls and fractures in the elderly population, a recommendation may be issued with the aim of preventing some of the consequences of falls that affect quality of life and the ensuing personal, health and social costs. TRIAL REGISTRATION ClinicalTrials.gov: NCT01452243
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Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study.
Sanders, KM, Stuart, AL, Merriman, EN, Read, ML, Kotowicz, MA, Young, D, Taylor, R, Blair-Holt, I, Mander, AG, Nicholson, GC
BMC medical research methodology. 2009;:78
Abstract
BACKGROUND Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. METHODS The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. RESULTS Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods. CONCLUSION The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected. TRIAL REGISTRATION ISRCTN83409867 and ACTR12605000658617.
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Effects of 3- and 5-year treatment with risedronate on bone mineralization density distribution in triple biopsies of the iliac crest in postmenopausal women.
Zoehrer, R, Roschger, P, Paschalis, EP, Hofstaetter, JG, Durchschlag, E, Fratzl, P, Phipps, R, Klaushofer, K
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2006;(7):1106-12
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Abstract
UNLABELLED Long-term effects of risedronate on bone mineralization density distribution in triple transiliac crest biopsies of osteoporotic women were evaluated. In this double-blinded study, 3- and 5-year treatment with risedronate increased the degree and homogeneity of mineralization without producing hypermineralization. These changes at the material level of bone could contribute to risedronate's antifracture efficacy. INTRODUCTION Risedronate, a nitrogen-containing bisphosphonate, is widely used in the treatment of osteoporosis. It reduces bone turnover, increases BMD, and decreases fracture risk. To date, there are no data available on the long-term effects of risedronate on bone mineralization density distribution (BMDD) in humans. MATERIALS AND METHODS Osteoporotic women enrolled in the VERT-NA trial received either risedronate (5 mg/day, orally) or placebo for up to 5 years. All subjects received calcium and vitamin D supplementation if deficient at baseline. Triple iliac crest biopsies were collected from a subset of these subjects at baseline and 3 and 5 years. BMDD was measured in these biopsies using quantitative backscattered electron imaging, and the data were also compared with a normal reference group. RESULTS At baseline, both risedronate and placebo groups had a lower degree and a greater heterogeneity of mineralization as well as an increase in low mineralized bone compared with the normal reference group. The degree of mineralization increased significantly in the risedronate as well as in the placebo group after 3- and 5-year treatment compared with baseline. However, the degree of mineralization did not exceed that of normal. Three-year treatment with risedronate significantly increased the homogeneity of mineralization and slightly decreased low mineralized bone compared with placebo. Surprisingly with 5-year risedronate treatment, heterogeneity of mineralization increased compared with 3-year treatment, which might indicate an increase in newly formed bone. CONCLUSIONS Long-term treatment with risedronate affects the homogeneity and degree of mineralization without inducing hypermineralization of the bone matrix. These changes at the material level of the bone matrix may contribute to risedronate's antifracture efficacy in osteoporotic patients.
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The effect of demineralized bone matrix-calcium sulfate with vancomycin on calcaneal fracture healing and infection rates: a prospective study.
Bibbo, C, Patel, DV
Foot & ankle international. 2006;(7):487-93
Abstract
BACKGROUND Displaced intra-articular calcaneal fractures may have a central cancellous bone defect area. We hypothesized that human demineralized bone matrix (DBM) calcium sulfate (CaSO(4)) might act as a reasonable alternative to autograft in calcaneal fractures. When combined with antibiotic powder, this bone graft substitute also may act as a local antibiotic delivery device. This is the first clinical study evaluating bone healing and complications associated with DBM-calcium sulfate bone graft substitute in the treatment of displaced intra-articular calcaneal fractures with a central cancellous bone defect. METHODS Over a 29-month period, 33 displaced intra-articular calcaneal fractures with central cancellous defects were treated with open reduction and internal fixation (ORIF) and grafting with vancomycin/DBM-calcium sulfate bone graft substitute. Eleven fractures without bone defects were treated with ORIF only. Patient demographics, medical history, and CT fracture classification were recorded. Postoperatively, fractures were monitored every 2 weeks for healing and complications. RESULTS The mean time to union was 8.2 weeks in the grafted, while the control group mean time to union was 10.4 weeks (p = 0.0117). Wound problems occurred in five (15%) of the 33 patients with grafting, all in type III fractures with severe soft-tissue swelling, and included two minor wound healing delays, and three serious wound problems. At a mean followup time of 22.4 months, no DBM-calcium sulfate grafted calcaneus demonstrated evidence of osteomyelitis. CONCLUSIONS This is the first study examining human DBM-calcium sulfate bone graft substitute to treat displaced intra-articular calcaneal fractures. Based on these initial data, human DBM-calcium sulfate acted as an acceptable and safe autograft alternative in displaced intra-articular calcaneal fractures with moderate (5 cc to 10 cc) central cancellous bone defects.
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[Drug therapy for prevention of falls and fractures].
Ringe, JD
Medizinische Klinik (Munich, Germany : 1983). 2006;:1-5
Abstract
The primary goal in the practical management of osteoporosis is to prevent first or subsequent fractures and thereby to avoid acute or chronic pain and progressive skeletal deformity. Therapeutic strategies should always take the complex pathogenetic mechanisms of fractures into account, especially the fact that mechanical impacts and falls play an important role in the majority of fracture events. Accordingly, recommendations to patients and the selection of drugs should aim at both, falls and fractures. In this context there is an increasing interest in the dual effects of vitamin D on bone and muscle. Controlled studies proved that adequate vitamin D supplementation is able to improve muscle strength, coordination and body sway and thereby reduce the risk of falls and fractures. Alendronate has been studied extensively by large trials of high quality and its efficacy to reduce the risk of vertebral and nonvertebral fractures is in line with the criteria of evidence-based medicine. The innovative combination of 70 mg alendronate with 2,800 IU vitamin D in a once-weekly tablet guarantees a basic supply with this important prohormone for bone and muscle. Due to a regular combined intake an improved compliance can be anticipated which will be followed by better therapeutic results in osteoporosis patients with increased fracture risk.
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Effect of alendronate on bone mineral density and biochemical markers of bone turnover in type 2 diabetic women: the fracture intervention trial.
Keegan, TH, Schwartz, AV, Bauer, DC, Sellmeyer, DE, Kelsey, JL, ,
Diabetes care. 2004;(7):1547-53
Abstract
OBJECTIVE Alendronate sodium (ALN) increases bone mineral density (BMD) in heterogeneous populations of postmenopausal women, but its effect is unknown in women with type 2 diabetes. The objective of this project was to compare changes in BMD during 3 years of ALN treatment versus placebo in diabetic women. RESEARCH DESIGN AND METHODS We used data from the Fracture Intervention Trial, a randomized blinded placebo-controlled trial conducted at 11 centers in which 6458 women aged 54-81 years with a femoral neck BMD of or=200 mg/dl. RESULTS In diabetic women, 3 years of ALN treatment was associated with increased BMD at all sites studied, including 6.6% at the lumbar spine and 2.4% at the hip, whereas women in the placebo group experienced a decrease in BMD at all sites except the lumbar spine. The safety/tolerability of ALN was similar to placebo, except for abdominal pain, which was more likely in the ALN group. CONCLUSIONS ALN increased BMD relative to placebo in older women with type 2 diabetes and was generally well tolerated as a treatment for osteoporosis. Increases in BMD with ALN therapy compared with placebo were similar between women with and without diabetes.