Fluoxetine (Prozac) Did Not Reduce Risk of Depression After Stroke, But Did Raise Risk of Fractures

MedicalResearch.com Interview with:

Prof .Gillian Mead Chair of Stroke and Elderly Care Medicine

Prof. Mead

Prof. Gillian Mead
Chair of Stroke and Elderly Care Medicine

Prof Martin Dennis Chair of Stroke Medicine

Prof. Dennis

Prof. Martin Dennis
Chair of Stroke Medicine

Centre for Clinical Brain Sciences
The University of Edinburgh

 


MedicalResearch.com: What is the background for this study?

Response: We are both practicing stroke physicians as well as clinical trialists. Therefore our interest in this area was triggered by the exciting results of the FLAME trial in 2011. This appeared to indicate that fluoxetine might boost the recovery of stroke patients. Potentially this was very important given the increasing numbers of people having disability due to stroke, and the fact that fluoxetine is inexpensive and could be introduced very easily into clinical practice. We were further encouraged by the large numbers of small RCTs we identified when we carried out a Cochrane systematic review on the topic. These trials provided more evidence of potential benefit but there was evidence that trials of greater quality showed less benefit, and benefits were greater in patients who were depressed. We felt there was a need for more evidence derived from much larger numbers of patients.

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Genetic Testing Could Identify Individuals At Risk of Osteoporosis

MedicalResearch.com Interview with:

Stuart Kim - PhD Professor of Developmental Biology, Emeritus Bio-X Affiliated Faculty James H. Clark Center Stanford University

Dr. Kim

Stuart Kim PhD
Professor of Developmental Biology, Emeritus
Bio-X Affiliated Faculty
James H. Clark Center
Stanford University 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Osteoporosis is caused by a reduction in bone mass, and leads to a high incidence of bone fracture because the weakened bone is less able to withstand the stress of slips and falls. Osteoporosis affects millions of elderly, is responsible for as many as 50% of fractures in women and 25% of fractures in men over the age of 50, and accounts for $19 billion in annual health care costs in the US. Identification of people with an increased genetic risk for osteoporosis could reduce the incidence of bone fracture. Low BMD is also a risk factor for stress fractures. For athletes and military personnel undergoing harsh rigors of training, stress fractures are common injuries that limit playing time, military effectiveness and competitive success.

Using data from UK Biobank, a genome-wide association study identified 1,362 independent SNPs that clustered into 899 loci of which 613 are new. These data were used to train a genetic algorithm using 22,886 SNPs as well as height, age, weight and sex as predictors. Individuals with low genetic scores (about 2% of those tested) showed a 17-fold increase in risk for osteoporosis and about a 2-fold increase in risk of fractures. Continue reading

Low Magnesium May Be Linked To Increased Risk of Hip Fractures

MedicalResearch.com Interview with:

Dr Setor Kunutsor Ba(Legon), MBChB(Legon), MA(Cantab), PhD(Cantab) Research Fellow Musculoskeletal Research Unit University of Bristol

Dr. Kunutsor

Dr Setor Kunutsor Ba(Legon), MBChB(Legon), MA(Cantab), PhD(Cantab)
Research Fellow
Musculoskeletal Research Unit
University of Bristol

MedicalResearch.com: What is the background for this study?

Response: Bone fractures are one of the leading causes of disability and ill health especially among the ageing population and are a burden to health care systems. There is established evidence that calcium and vitamin D play an important role in bone health.

Magnesium is an essential trace element, being the second most abundant intracellular cation after potassium and the fourth most abundant cation in the body. It serves several important functions in the body, which include protein synthesis, nucleic acid synthesis, enzymatic reactions, and has also been shown to be cardio-protective. It is also an important component of bone, with majority (67 percent) of total body magnesium known to be found in the bone tissue. There have been suggestions from both human and animal experiments that magnesium may have a beneficial effect on bone health; however, its relationship with fractures is not very certain.

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Low-Intensity Ultrasound Not Effective In Accelerating Healing of Tibial Fractures

MedicalResearch.com Interview with:

Jason Busse PhD Associate Professor, Department of Anesthesia McMaster University Hamilton, ON

Jason Busse

Jason Busse PhD
Associate Professor, Department of Anesthesia
McMaster University
Hamilton, ON

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our group previously reviewed the evidence regarding the effectiveness of low-intensity pulsed ultrasound (LIPUS) for fracture healing. We found moderate to very low quality evidence for LIPUS in accelerating functional recovery among patients with fracture, and that most trials only explored effects on surrogate outcomes (e.g. radiographic healing); only five of 13 trials directly assessed functional end points – of these, one was positive. We concluded that large trials of high methodological quality, focusing on patient important outcomes such as quality of life and return to function, were needed to establish the role of LIPUS in fracture healing.

We have now completed such a study. Our large, international trial of LIPUS for surgically managed tibial fractures found the addition of LIPUS does not improve functional recovery or accelerate radiographic healing.

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Romosozumab Has Potential To Reduce New Vertebral Fractures at 12 Months

MedicalResearch.com Interview with:

MedicalResearch.com Interview with: Felicia Cosman, M.D.

Dr. Felicia Cosman

Felicia Cosman, M.D.
Medical Director of the Clinical Research Center
Helen Hayes Hospital
Professor of Medicine
Columbia University College of Physician and Surgeons
New York
Editor-in-Chief, Osteoporosis International

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Amgen and UCB presented detailed data from the Phase 3 FRAME study in an oral session at ASBMR 2016, and the data were also published in the New England Journal of Medicine. Additionally, the FRAME abstract has been awarded the 2016 ASBMR Most Outstanding Clinical Abstract Award. The FRAME data show significant reductions in both new vertebral and clinical fractures in postmenopausal women with osteoporosis.

Patients receiving a monthly subcutaneous 210 mg dose of romosozumab experienced a statistically significant 73 percent reduction in the relative risk of a vertebral (spine) fracture through 12 months, the co-primary endpoint, compared to those receiving placebo (fracture incidence 0.5 percent vs. 1.8 percent, respectively [p<0.001]). By six months, new vertebral fractures occurred in 14 romosozumab and 26 placebo patients; between six to 12 months, fractures occurred in two versus 33 additional patients in each group, respectively.

Patients receiving romosozumab experienced a statistically significant 36 percent reduction in the relative risk of a clinical fracture, a secondary endpoint, through 12 months compared to those receiving placebo (fracture incidence 1.6 percent vs. 2.5 percent, respectively [p=0.008]).

In patients who received romosozumab in year one, fracture risk reduction continued through month 24 after both groups transitioned to denosumab treatment through the second year of the study: there was a statistically significant 75 percent reduction in the risk of vertebral fracture at month 24 (the other co-primary endpoint) in patients who received romosozumab followed by denosumab vs. placebo followed by denosumab (fracture incidence 0.6 percent vs. 2.5 percent, respectively [p<0.001]).

Clinical fractures encompass all symptomatic fractures (both non-vertebral and painful vertebral fractures; all clinical fractures assessed in the FRAME study were symptomatic fragility fractures. A 33 percent reduction in relative risk of clinical fracture was observed through 24 months after patients transitioned from romosozumab to denosumab compared to patients transitioning from placebo to denosumab (nominal p=0.002, adjusted p=0.096).

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Key Risk Factors of Non-Healing Bone Fractures Identified

MedicalResearch.com Interview with:

R. Grant Steen, PhD Medical Affairs, Bioventus LLC Durham, North Carolina

Dr. R. Grant Steen

R. Grant Steen, PhD
Medical Affairs,
Bioventus LLC
Durham, North Carolina

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: When we started this research, it was really only guesswork as to how big a problem fracture nonunion really is. What we’ve done is to work with an enormous database of patient health claims, with two goals.

First, we wanted to characterize how common fracture nonunion is among patients across a wide age range.
Second, we wanted to identify risk factors that make a patient more likely to have problems healing.

We’ve now succeeded in both aims. We know that roughly 5% of fracture patients will go to nonunion, and we know a whole host of risk factors that predispose them to do so.
Most of the risk factors that we’ve identified—with a few exceptions—would not be a surprise to physicians who treat fracture patients. However, what we’ve done is to put all of these risk factors in a broader context, so that we know which risk factors are most important and which are less so.

For example, it has been known for a long time that smoking is a risk factor for nonunion. What we’ve shown is that, in the scheme of things, it’s not all that important. Let me be more precise here, because this is an important point. If all you know about a patient is that they smoke, we’ve shown that smoking is associated with a 62% increase in risk of nonunion. That’s a lot. But, as you learn more about that patient and can factor that new knowledge into a risk prediction, it turns out that smoking, all by itself, increases the risk of nonunion by only about 20%. However, smoking is a surrogate marker for a range of other risk factors that also increase risk, including male gender, cardiovascular disease, obesity, vitamin D deficiency, alcoholism, and so on. Once you factor these separate risk factors into your new nonunion prediction, you have a much more nuanced—and probably much more accurate—prediction of nonunion risk.
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Patients Remain On High Risk Drugs Even After A Fragility Fracture

MedicalResearch.com Interview with:

Jeffrey Munson, MD, MSCE Assistant Professor The Dartmouth Institute for Health Policy & Clinical Practice Assistant Professor, Department of Medicine Geisel School of Medicine at Dartmouth

Dr. Jeffrey Munson

Jeffrey Munson, MD, MSCE
Assistant Professor
The Dartmouth Institute for Health Policy & Clinical Practice
Assistant Professor, Department of Medicine
Geisel School of Medicine at Dartmouth

MedicalResearch.com: What is the background for this study? 

Response: Fragility fractures due to osteoporosis are a common and costly event among older Americans. Patients who experience one fragility fracture are at increased risk to have a second fracture. Our group is interested in exploring ways in which the risk of a second fracture could be reduced.

In this paper, we studied prescription drug use both before and after fracture. We know many prescription drugs have been shown to increase the risk of fracture, but we don’t know whether doctors try to reduce the use of these drugs after a fracture has occurred. Our study was designed to answer this question.

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Over 50% Reduction in Facial Fractures from Car Accidents With Combined Seat Belt and Air Bag use

MedicalResearch.com Interview with:
Dr. David A. Hyman, MD
Division of Otolaryngology–Head and Neck Surgery
Department of Surgery
University of Wisconsin School of Medicine and Public Health
Madison

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Motor vehicle collisions represent a significant source of facial fractures seen at US trauma centers. In the last few decades there have been significant advances in airbag technology as well as a national legislative push regarding seat belt use which has led to increased safety device use. With these trends, we sought to assess the incidence of facial fractures in patients who present to US trauma centers as well as to analyze what effect restraint devices have on the likelihood of facial fractures after motor vehicle collisions. This analysis was performed using National Trauma Data Bank data from 2007-2012. We found the incidence of at least one facial fracture after a motor vehicle collision was 10.9% with nasal fracture being the most common facial fracture. Based on our analysis of more than 56 thousand patients with a facial fracture, we found that use of an airbag alone reduced the likelihood of a facial fracture by 18% while use of a seat belt alone reduced likelihood by 43%. Use of both reduced the likelihood of facial fractures in a crash by 53%. Younger age, male sex, and use of alcohol increased the likelihood of facial fracture.

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Normal Bone Density in Men Does Not Prevent Fractures—Fall Prevention Still Needed

Margaret L. Gourlay, MD, MPH Assistant Professor UNC Department of Family Medicine Chapel Hill, NC 27599-7595

Dr. Margaret Gourlay

MedicalResearch.com Interview with:
Margaret L. Gourlay, MD, MPH
Assistant Professor
UNC Department of Family Medicine
Chapel Hill, NC 27599-7595

Medical Research: What is the background for this study? What are the main findings?

Dr. Gourlay: While clinical practice guidelines universally recommend bone density screening for fracture prevention in women aged 65 years and older, minimal data exist to guide bone density screening in older men. We studied how often bone density screening tests should be ordered in men, using data from the Osteoporotic Fractures in Men (MrOS) Study. MrOS is the largest and longest-running (since 2000) US study of bone density and fracture in men aged 65 and older.

After peak bone mass is reached in young adulthood, both men and women lose bone density as they get older. Based on our earlier findings in older women, we expected that men aged 65 and older with higher bone density T-score measurements (T-score >-1.50) on a first (baseline) bone density test would have a substantially longer estimated time to develop the lowest level of bone density (osteoporosis) than men with better baseline measurements. Clinicians want to know the time to osteoporosis because they prescribe osteoporosis treatments to prevent future fractures in elderly patients.

As expected, we found that the men with higher baseline bone density had a much slower transition to osteoporosis compared to men with lower bone density. In fact, only nine out of 4203 (0.2%) of men with higher baseline bone density developed osteoporosis after an average of 8.7 years of bone density follow-up. That was much lower than we expected and is good news for men who have favorable scores on their first bone density test. Men who had lower baseline bone density measurements developed osteoporosis faster.

Unfortunately, maintaining bone density above the osteoporosis range did not guarantee that men remained fracture-free.   Most of the major osteoporotic fractures (broken hip, spine, wrist or upper arm/shoulder) occurred in men who did not have osteoporosis. This might be because they had accidents or injuries that broke their bones despite their bone density being above the thinnest range.

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Black Tea Linked To Lower Fractures in Elderly Women

MedicalResearch.com Interview with:
Prof. Jonathan M. Hodgson
School of Medicine and Pharmacology
Royal Perth Hospital
University of Western Australia
Perth, Australia

MedicalResearch What is the background for this study? What are the main findings?

Prof. Hodgson: Flavonoids are a class of phytochemicals present at high levels in tea. Observational studies have found that higher tea and flavonoid intakes are associated with higher bone mineral density. However, the relationships of tea and flavonoid intakes with fracture risk are not clear. We therefore examined the relationship of black tea drinking and flavonoid intake with fracture risk in a population of women aged over 75 years followed for 10 years. We found that a higher intake of black tea and particular classes of flavonoids, some of which are derived primarily from tea, were associated with lower risk of fracture-related hospitalizations in these elderly women.

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Menopausal SSRIs Increases Risk of Bone Fractures

MedicalResearch.com Interview with:
Dr Matthew Miller
Department of Health Science Northeastern University
Department of Health Policy and Management,
Harvard T.H. Chan School of Public Health Harvard University
Boston, Massachusetts

and Yi-Han Sheu
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Harvard University Boston, Massachusetts

Medical Research: What is the background for this study?

Response: Selective serotonin reuptake inhibitors (SSRIs) were recently approved by the FDA to treat vasomotor symptoms associated with menopause. No prior study has directly examined whether fracture risk is increased among perimenopausal women who initiate SSRIs or among a population of women without mental disorders more generally..

Medical Research: What are the main findings?

Response: We found that SSRIs treatment for non-psychiatric conditions at doses customarily used to treat depression is, all else equal, associated with higher rates of fractures — an effect that first became evident several months after beginning treatment and, importantly, persisted over the five year study period.

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Nonsurgical Treatments May Equal Surgery For Many Broken Shoulders

Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital MiddlesbroughMedicalResearch.com Interview with:
Prof. Amar Rangan
Clinical Professor, Trauma & Orthopaedic Surgery
School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon
The James Cook University Hospital Middlesbrough

Medical Research: What is the background for this study? What are the main findings?

Prof. Rangan: The majority of fractures of the proximal humerus (broken shoulders) occur in people older than 65 years. Although surgical treatment is being increasingly used for the more serious (displaced) fractures, it has been unclear whether surgical intervention (fracture fixation or humeral head replacement) produces consistently better outcomes than non-surgical treatment (arm-sling); both followed by physiotherapy.

Our multicentre randomized controlled trial (ProFHER), funded by the UK National Institute for Health Research’s Health Technology Assessment Programme, recruited 250 patients aged 16 years or older (mean age, 66 years) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 after sustaining the most common types of acute displaced fracture of the proximal humerus.

Data for 231 patients (92.4% of 250) included in the primary analysis showed that there was no significant difference between the two treatment groups over two years or at 6, 12 and 24 months follow-up in self-reported pain and function scores. Nor were there significant differences on measures of health-related quality of life, complications related to surgery or shoulder fracture, later surgery or treatment for these complications, and death.

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Higher Social Class Linked To Lower Risk of Bone Fractures

Dr. Carolyn Crandall, M.D. Division of General Internal Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA, 90024, USAMedicalResearch.com Interview with:
Dr. Carolyn Crandall, M.D.
Division of General Internal Medicine,
David Geffen School of Medicine at University of California,
Los Angeles, CA, 90024, USA


MedicalResearch.com: What are the main findings of the study?

Dr. Crandall: We found that higher social class was linked with a lower risk of fractures among non-Caucasian women.  Compared with non-Caucasian women who had no more than a high school education, those with at least some postgraduate education had nearly 90% lower rates of non-traumatic fracture.  These results were present even after we accounted for income.
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Bone Mineral Density: Does Repeat Testing Improve Fracture Risk Prediction?

Sarah D. Berry MD MPH Institute for Aging Research, Hebrew Senior Life Boston, MassachusettsMedicalResearch.com Interview with:
Sarah D. Berry MD MPH
Institute for Aging Research, Hebrew Senior Life
Boston, Massachusetts

 

MedicalResearch.com: What are the main findings of the study?

Dr. Berry: Repeating a bone mineral density (BMD) screening test in 4 years provided little additional value beyond baseline BMD when assessing fracture risk. Also, the second BMD measure resulted in little change in risk classification that is commonly used in clinical management of osteoporosis.
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