Author Interviews, BMJ, Diabetes, Osteoporosis / 05.08.2022

MedicalResearch.com Interview with: Stig Larsen
 PhD Professor Emeritus Controlled Clinical Research Methodology and Statistics Norwegian University of Life Sciences Oslo, Norway

MedicalResearch.com:? What are the main findings?

Response: Osteoporosis is a major problem among elderly and malnourished people. Calcium, Vitamin D and Vitamin K are beneficial for bone health. Vitamin D stimulates calcium absorption and studies have shown that poor Vitamin K status intake is linked to low bone mass. Osteocalcin (OC) is a protein hormone found in the blood in activated and inactivated form. The activated form of Osteocalcin (cOC) binds calcium to bone tissue and plays an important role in regulating the metabolism. In addition, low levels of cOC are associated with insulin resistance, diabetes, and metabolic syndrome. It is desirable to have largest possible uOC, and vitamin K2 central in this process. The most important vitamin K2 variants in Jarlsberg® are the long-chain MK-7, -8, -9 and -9(4H), where lactic acid bacteria produce the first three, while MK-9(4H) is produced by Propionibacterium freudenreichii. The latter bacterium also produces the substance "1,4-dihydroxy-2- naphthoic acid" (DHNA), which has previously been shown to increase bone density in experimental mice. Two previous studies related to Jarlsberg® intake have been published:

  • The first study showed that cOC in the blood increased with increasing Jarlsberg® dose up to a daily intake of 57 grams of Jarlsberg®. Even more startling was that the total OC (tOC) level increased significantly, and that triglycerides and cholesterol were significantly reduced.1
  • The second study reproduced the findings from the first study and demonstrated additionally that the Jarlsberg dose of 57g/day could be reduced to 45 grams after 6 weeks without reducing the achieved level of tOC and vitamin K2.2

The BMJ-study3: The central variables measured in this study were the serum bone turnover markers (BTM); tOC and cOC, procollagen type 1 N-terminal propeptide (PINP) and serum cross-linked C- telopeptide type I collagen (CTX). Additionally, Vitamin K2 and Vitamin K status, serum calcium and serum magnesium were recorded together with the development in glycated hemoglobin (HbA1c), lipids and protein turnover. The participants in the study were randomly divided into two groups. One group of 41 healthy volunteer women of childbearing age ate 57 grams of Jarlsberg® per day and the other group of 25 women ate 50 grams of Camembert for 6 weeks. The Camembert was manufactured with a starting culture not producing Vitamin K2. The fat, protein, and energy content of the daily consumption of Jarlsberg® and Camembert is approximately the same. After 6 weeks, Camembert was replaced with 57 grams of Jarlsberg® per day for another 6 weeks. (more…)

Author Interviews, Brigham & Women's - Harvard, Endocrinology, Hip Fractures, NEJM, Osteoporosis, Vitamin D / 27.07.2022

MedicalResearch.com Interview with: Meryl S. LeBoff, MD Chief, Calcium and Bone SectionDirector of the Skeletal Health and Osteoporosis CenterDirector, Bone Density UnitDistinguished Chair in Skeletal Health and Osteoporosis Professor of Medicine, Harvard Medical School Endocrinology, Diabetes and Hypertension, Women's Health Brigham And Women's Hospital JoAnn E. Manson, MD, DrPH Professor, Epidemiology, Harvard T.H. Chan School Of Public Health Michael and Lee Bell Professor of Women's Health, Medicine, Harvard Medical School Chief, Preventive Medicine, Brigham And Women's Hospital Co-Director, Womens Health, Brigham And Women's Hospital   MedicalResearch.com:  What is the background for this study?  What are the main findings? Response: Osteoporosis is a major public health problem. Although supplemental vitamin D has been widely used to reduce the risk of fractures in the general population, studies of the effects of vitamin D on fractures, the most important bone health outcome, have been conflicting. Randomized controlled trials, the highest quality studies, from around the world have shown benefit, no effect, or even harm of supplemental vitamin D on risk of fractures. Some of the trials used bolus dosing, had small samples sizes or short study duration, and co-administered calcium. No large RCTS of this scale tested whether daily supplemental vitamin D (without co-administration with calcium) prevented fractures in the US population. To fill these knowledge gaps, we tested the hypothesis in this ancillary study to VITAL, whether daily supplemental vitamin D3 reduced the risk of incident total, non-spine and hip fractures in women and men in the US. (more…)
Author Interviews, Heart Disease, Menopause, Osteoporosis / 12.05.2021

MedicalResearch.com Interview with: Yeonyee E. Yoon, MD, PhD Associate Professor Division of Cardiology, Cardiovascular Center Seoul National University Bundang Hospital South Korea  MedicalResearch.com: What is the background for this study? Response: Although atherosclerotic cardiovascular disease (ASCVD) has been traditionally considered to affect men predominantly, it is nearly common in women. ASCVD is the leading cause of death in both men and women globally, and the population-adjusted risk of ASCVD mortality in women is significantly greater than that in men. Nevertheless, the current focus on the 10-year ASCVD risk estimated by a risk-scoring algorithm such as the Pooled Cohort Equation has shown unsatisfactory accuracy in women. Therefore, new strategies beyond the conventional risk stratification algorithm are needed to improve identification for women at high risk for ASCVD. ASCVD and osteoporosis are major age-related diseases contributing to significant morbidity and mortality in women, and previous epidemiologic studies have suggested a potential association between these diseases. Given that millions of women are screened for osteoporosis using dual-energy X-ray absorptiometry (DXA), potential associations between low bone mineral density (BMD) and ASCVD in women would provide an opportunity to improve the risk stratification of women without any additional costs. Therefore, we aimed to investigate whether the evaluation of BMD provides independent and incremental prognostic values for ASCVD prediction in women.  (more…)
Author Interviews, Lancet, Menopause, Orthopedics, Osteoporosis, UCLA / 05.05.2021

MedicalResearch.com Interview with: Carolyn Crandall, M.D. Professor, Medicine Health Sciences Clinical Professor, UCLA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previously-published studies had not examined in detail the risk of subsequent fractures after initial fractures in a large national sample of women in the us. Clinical guidelines mostly emphasize initial hip and spine fractures, but they do not emphasize fractures of other types.  We hypothesized that subsequent fracture risk would be higher after initial fracture even at locations other than the hip or the spine. (more…)
Asthma, Author Interviews, BMJ, Osteoporosis / 21.10.2020

MedicalResearch.com Interview with: Christos Chalitsios B.Sc, M.Sc PhD student Funded by British Medical Association (BMA) School of Medicine Division of Respiratory Medicine University of Nottingham City Hospital,Nottingham MedicalResearch.com: What is the background for this study? Response: Inhaled (ICS) and oral (OCS) corticosteroids play a crucial role in the control of airway inflammation in asthma. Given that the use of ICS in asthma is likely to increase with the recent change in GINA guidance recommending combined long-acting-β2-agonists with ICS at step 1 and the upward trend in prescribing of OCS, we sought to clarify the link between steroids, osteoporosis and FF in patients with asthma, stratifying the risk by dose, number of courses and type of steroids. The prevalence of patients receiving at least one bisphosphonate was also calculated. (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Osteoporosis / 28.07.2020

MedicalResearch.com Interview with: Daniel Hal Solomon, MD, MPH Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Rheumatology, Immunology Boston, MA 02115 Editor’s note: Prolia® is the trade name for denosumab.  MedicalResearch.com: What is the background for this study? Response: We conducted this study to assess whether delays in denosumab (injections were associated with an increased risk of fractures. In a prior study, we found that the improvements in bone mineral density were reduced among patients who delayed injections. (more…)
Author Interviews, JAMA, Osteoporosis / 26.11.2019

MedicalResearch.com Interview with: Pamela L. Lutsey, PhD Associate Professor Division of Epidemiology and Community Health University of Minnesota School of Public Health Minneapolis MedicalResearch.com: What is the background for this study? Response: Warfarin is prescribed to atrial fibrillation (AF) patients for the prevention of cardioembolic complications. However, whether it adversely impacts bone health is controversial. With the availability of alternate direct oral anticoagulant (DOAC) options, it is now possible to evaluate the comparative safety of warfarin in relation to fracture risk. (more…)
Author Interviews, JAMA, Osteoporosis, Weight Research / 01.11.2019

MedicalResearch.com Interview with: Radhika Seimon, PhD Research Fellow at the University of Sydney Amanda Salis, PhD - Professor of Obesity Research at the University of Sydney Senior Research Fellow National Health and Medical Research Council of Australia  MedicalResearch.com: What is the background for this study? Response: Total meal replacement diets are severely energy-restricted diets that involve replacing all or almost all foods with nutritionally replete meal replacement products such as shakes, soups, or bars (i.e. total diet replacement). They are the most effective dietary treatment for obesity, resulting in greater short- and long-term weight loss compared with conventional food-based diets. However, there are concerns that total meal replacement diets may adversely affect body composition, notably lean mass and bone mineral density. (more…)
Author Interviews, Geriatrics, Hip Fractures, JAMA, Orthopedics, Osteoporosis / 17.06.2019

MedicalResearch.com Interview with: Kristine E. Ensrud MD MPH Professor of Medicine and Epidemiology and Community Health University of Minnesota Core Investigator, Center for Care Delivery and Outcomes Research Minneapolis VA Health Care System  MedicalResearch.com: What is the background for this study? Response: Women aged 80 years and older, a rapidly growing segment of the population, account for the majority of hip fractures in the United States. Hip fractures account for 72% of fracture-related health care expenditures and lead to significant morbidity and mortality. However, many late-life women at high risk of hip fracture are undiagnosed. Clinicians have difficulty identifying late-life women most likely to benefit from osteoporosis screening and interventions to prevent hip fracture in part due to concerns about comorbidity burden and prognosis in this patient population. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Orthopedics, Osteoporosis, Surgical Research / 15.05.2019

MedicalResearch.com Interview with: Elaine W. Yu, MD, MMSc Assistant Professor,  Harvard Medical School Director, Bone Density Center Endocrine Unit, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Roux-en-Y gastric bypass (RYGB) is a popular surgical weight loss procedure.  We have previously shown that gastric bypass leads to rapid high-turnover bone loss. Bariatric procedures are being increasingly performed in older adults, and the clinical consequences of gastric bypass-associated skeletal changes in this vulnerable population have been unclear to date.  Thus, we used Medicare claims data to investigate fracture risk among older adults after gastric bypass, and in comparison to adults who received another bariatric procedure called adjustable gastric banding (AGB), which is thought to have fewer negative bone effects. In our analysis, we found that patients undergoing Roux-en-Y gastric bypass were 73% more likely to fracture than those undergoing AGB. Importantly, we found that hip fracture risk increased nearly 180% after RYGB, and that fracture rates in patients aged 65 or older were similar to the overall group.  (more…)
Author Interviews, Cost of Health Care, Geriatrics, Osteoporosis / 08.10.2018

MedicalResearch.com Interview with: Kandice A. Kapinos, Ph.D. Economist Professor RAND Corporation Pardee RAND Graduate School  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The economic burden of osteoporotic fractures is substantial with studies estimating the annual healthcare cost burden between $10 to 17 billion. Although estimates from individual studies vary, most studies assessing costs after a fracture only explore up to twelve months following a fracture. There is little investigation of how fracture patients’ costs evolve over a longer post-fracture period. As osteoporotic fractures are one of the most common causes of disability among older adults and can translate into greater medical costs, we focused on studying Medicare beneficiaries. In fact, previous research has suggested that most of the increase in Medicare spending over time can be explained from costs associated with treating higher risk Medicare beneficiaries. Our objective in this study was to compare health care costs over a 3-year period of those who experienced a fracture to those who did not among a sample of Medicare beneficiaries who were at an increased risk of having a fracture. Consistent with previous studies, we found a significant increase in expenditures in the year immediately following a fracture relative to controls: almost $14,000 higher for fractures relative to controls. However, at 2 and 3-years post-fracture, there were no significant differences in the change in expenditures between fracture cases and controls. We note that these findings may be different for beneficiaries living in skilled nursing facilities or other non-community-based settings. (more…)
Author Interviews, NEJM, Osteoporosis / 04.10.2018

MedicalResearch.com Interview with: Prof Ian Reid Faculty of Medical and Health Sciences University of Auckland Auckland New Zealand  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with less marked bone loss (referred to as osteopenia) is unknown. Most fractures in postmenopausal women occur in osteopenic patients, so therapies with efficacy in osteopenia are needed. (more…)
Author Interviews, Genetic Research, Osteoporosis, PLoS, Stanford / 29.07.2018

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, JAMA, Osteoporosis / 28.06.2018

MedicalResearch.com Interview with: Chien-Wen Tseng, M.D., M.P.H., M.S.E.E. Hawaii Medical Service Association Endowed Chair in health services and quality research Associate professor, and the Associate research director Department of Family Medicine and Community Health University of Hawaii John A. Burns School of Medicine  MedicalResearch.com: What is the background for this recommendation statement? What are the main findings and recommendations? Response: Osteoporosis is a condition where bones become weak and can break or fracture more easily. These fractures can happen at the spine, hip, and other locations, and can have serious health consequences such as pain, limited mobility, or even death. By 2020, more than 12 million Americans over the age of 50 are expected to have osteoporosis and two million fractures occur yearly. Since people often may not know they have osteoporosis until they have a fracture, the U.S. Preventive Services Task Force looked at the evidence to see if screening for osteoporosis can help to prevent fractures. We found that screening for and treating osteoporosis can prevent fractures in women ages 65 and older and in younger women who have been through menopause and have additional factors that put them at increased risk for osteoporosis. In men, more research is needed to know if routine screening and treatment for osteoporosis can prevent fractures. (more…)
Author Interviews, Bone Density, Dermatology, Osteoporosis / 21.06.2018

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois MedicalResearch.com: What is the background for this study? Response: Persons with atopic dermatitis have a number of risk factors for osteopenia and osteoporosis, including systemic atopy and inflammation, being less physically active and using a lot of topical and/or systemic corticosteroids. We aimed to determine whether adults with atopic dermatitis in fact have higher rates of physician-diagnosed osteopenia and osteoporosis. (more…)
Author Interviews, Hip Fractures, Orthopedics, Osteoporosis / 14.05.2018

MedicalResearch.com Interview with: “Just a hairline fracture...” by Gloria Bell is licensed under CC BY 2.0Brittany Bindon, MD Department of Internal Medicine University of Chicago Chicago, Illinois MedicalResearch.com: What is the background for this study? Response: Bisphosphonates are commonly used in the treatment of osteoporosis, however, they have been associated with rare, severe side effects such as osteonecrosis of the jaw and atypical femoral fractures. As a result, bisphosphonate drug holidays have become common in clinical practice though currently, there are minimal data on the safe duration of these drug holidays. We sought to further characterize the clinical and laboratory parameters associated with increased fracture risk in patients on bisphosphonate drug holiday. (more…)
Author Interviews, Breast Cancer, Osteoporosis / 05.05.2018

MedicalResearch.com Interview with: Chenfang Dong, Ph.D & M.D. Professor Department of Pathology and Pathophysiology Zhejiang University School of Medicine,  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Basal-like breast cancer (BLBC), which generally falls into the triple-negative breast cancer subtype, is associated with a poor clinical outcome due to few treatment options and poor therapeutic response; thus there is a pressing need to elucidate the determinants of aggressiveness in BLBC and identify potential therapeutic targets for this challenging disease. By analyzing gene expression profiles of breast cancer in multiple publicly available datasets that contain over 5000 cases, we have identified that UDP-galactose ceramide galactosyltransferase (UGT8), a key enzyme in the sulfatide biosynthetic pathway, promotes BLBC progression by activating sulfatide-αVβ5 axis. Importantly, we identify that zoledronic acid (ZA), a marketed drug for treating osteoporosis and bone metastasis, is a direct inhibitor of UGT8, which has the potential to become a valuable targeted drug for treating Basal-like breast cancer.  (more…)
Author Interviews, Bone Density, Dermatology, Endocrinology, Osteoporosis, Pediatrics / 03.12.2017

MedicalResearch.com Interview with: Diana L. Cousminer, PhD Division of Human Genetics Children's Hospital of Philadelphia Philadelphia, PA 19104 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Osteoporosis is a significant public health burden, with origins early in life. Later puberty and lower adolescent bone mineral density are both risk factors for osteoporosis. Geneticists have identified hundreds of genetic variants across the genome that impact pubertal timing, and we found that collectively this variation also plays a role in bone mineralization during adolescence. Additionally, we found that later puberty caused lower adult bone density. (more…)
Accidents & Violence, Author Interviews, Exercise - Fitness, Frailty, Geriatrics, JAMA, Osteoporosis / 07.11.2017

MedicalResearch.com Interview with: Andrea C. Tricco PhD, MSc Scientist and Lead of the Knowledge Synthesis Team Associate Professor Dalla Lana School of Public Health, University of Toronto Associate Editor Journal of Clinical Epidemiology, BMC Medical Research Methodology, Systematic Reviews MedicalResearch.com: What is the background for this study? Response: Falls are the leading cause of injury among older adults and account for $2 billion in direct health-care costs annually ($31 billion in costs to Medicare in the United States in 2012). We aimed to determine which types of fall-prevention programs may be effective for reducing falls in older people. MedicalResearch.com: What are the main findings? Response: Exercise, along with vision assessment and treatment, as well as an assessment and possible modification of a person’s living environment, reduced the risk of injurious falls by 23% compared to usual care. (more…)
Author Interviews, Osteoporosis, Pharmacology / 30.08.2017

MedicalResearch.com Interview with: Dieter Bromme, Ph.D. Professor and Canada Research Chair The University of British Columbia Faculty of Dentistry Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Every three seconds somebody will fracture a bone because of osteoporosis. Several treatments are available to slow down bone loss but all of them have shortcomings ranging from poor bone quality to various side effects. Thus new treatment strategies and novel drug targets are needed that promise efficacy without significant adverse reactions. One of the novel promising targets was cathepsin K, a protease solely responsible for the degradation of our organic bone matrix. Major efforts and funds were spent by the pharmaceutical industry to develop potent and selective cathepsin K inhibitors. These inhibitors were highly effective in preserving bone in clinical trials. Despite the good news, cathepsin K inhibitors were never approved because of various non-skeletal side effects. We hypothesized that these side effects are not caused by off-target effects (drugs react with undesired targets) but by on-target effects. Most drugs that target enzymes are active site-directed compounds and thus will stop the entire activity of the target enzyme. If the target is a multifunctional enzyme, safety problems are preprogrammed. Based on our studies to understand the molecular mechanism of collagen degradation by cathepsin K, we developed the concept of ectosteric enzyme inhibition, which allowed us to identify highly selective collagenase inhibitors of this protease. In our study, we used a red sage-derived small molecule that selectively blocked the collagenase activity of cathepsin K and thus consequently bone degradation in an osteoporosis mouse model without affecting other known functions of the protease. The crucial difference might be that the red sage inhibitor did not block the cathepsin K-mediated degradation of TGF-ß1, a growth factor involved in fibrotic pathologies described in the clinical trials. TGF-ß1 degradation is blocked by these inhibitors and thus accumulates in tissues, causing fibrosis. (more…)
Author Interviews, BMJ, Osteoporosis / 23.05.2017

MedicalResearch.com Interview with: Jean-Yves Reginster M.D.,PH.D. Professor of Epidemiology, Public Health and Health Economics Head of the Bone and Cartilage Metabolism Unit University of Liège MedicalResearch.com: What is the background for this study? What are the main findings? Response: Whereas several recommendations, issued by scientific societies, recommend to use Symptom-Modifying Slow Acting Drugs (SYSADOAs) for the symptomatic and structural management of osteoarthritis, no medication is currently registered, in this particular indication, by the European Medicines Agency (EMA) or by the Food and Drug Administration (FDA). This study is the first study, conducted, with a SYSADOA which fully complies with the requirements of the EMA for the assessment of drugs to be used in the treatment of osteoarthritis, i.e. a six-month duration, two co-primary endpoints (pain and function) and a three-arm design, with a placebo and an active comparator. The main findings are that pharmaceutical grade chondroitin sulfate provides an improvement in pain and function, which is greater than placebo and not distinguishable from celecoxib, a non-steroidal anti-inflammatory drug currently licensed for the symptomatic management of osteoarthritis. (more…)
Author Interviews, Heart Disease, JAMA, Osteoporosis / 27.03.2017

MedicalResearch.com Interview with: Wallis CY Lau BSc Centre for Safe Medication Practice and Research Department of Pharmacology and Pharmacy Li Ka Shing Faculty of Medicine The University of Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Warfarin is a vitamin K antagonist (VKA) oral anticoagulant used for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), a common heart rhythm disorder. It works by interfering with vitamin K-dependent reactions in the process of blood clot formation. As these reactions also play a role in bone mineralization, there is concern that warfarin use may be linked with osteoporotic fracture. Despite the concerns for fracture risk, warfarin had been an inevitable treatment choice for over 50 years as there were no other alternatives available. Dabigatran is the first non-VKA oral anticoagulant (NOAC) approved for use in patients with NVAF. Recently, an animal study reported that use of dabigatran is associated with a better bone safety profile compared to warfarin in rats, suggesting a potential for a lower risk of osteoporotic fractures over warfarin. However, the actual risk of osteoporotic fractures with dabigatran use in human remains unclear. Therefore, we conducted a population-based cohort study to compare the risk of osteoporotic fractures in patients with NVAF treated with dabigatran and warfarin. (more…)
Author Interviews, Biomarkers, Exercise - Fitness, Osteoporosis / 23.03.2017

MedicalResearch.com Interview with: Pamela S. Hinton, Ph.D. Associate Professor & Director of Graduate Studies Department of Nutrition and Exercise Physiology Columbia MO 65211 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study builds on our previous work showing that weight-bearing, high-impact physical activity throughout the lifespan is associated with greater bone mass in men.  We previously conducted a 12-month randomized trial of the effectiveness of resistance training versus jump training to increase bone mass in men with low bone density of the hip or lumbar spine. The current study is a follow up study investigating how exercise might work to increase bone mass. The main findings are that exercise reduced circulating levels of a bone protein that inhibits bone formation (sclerostin) and increased levels of insulin-like growth factor-I (IGF-I), a hormone with osteogenic effects. (more…)
Author Interviews, JAMA, Orthopedics, Osteoporosis, Testosterone / 23.02.2017

MedicalResearch.com Interview with: Tony M. Keaveny, Ph.D. Professor, Departments of Mechanical Engineering and Bioengineering; Co-Director, Berkeley BioMechanics Laboratory University of California Berkeley, CA 94720-1740 MedicalResearch.com: What is the background for this study? Response: As men age, they experience decreased serum testosterone concentrations, decreased bone mineral density (BMD) and increased risk of fracture. While prior studies have been performed to determine the effect of testosterone treatment on bone in older men, for various reasons those studies have been inconclusive. The goal of this study was to overcome past limitations in study design and determine if testosterone treatment — versus a placebo — in older men with low testosterone would improve the bone. Specifically, we used 3D quantitative CT scanning to measure changes in BMD and engineering “finite element analysis” to measure changes in the estimated bone strength, both at the spine and hip. The study was performed on over 200 older men (> age 65) who had confirmed low levels of serum testosterone. (more…)
Author Interviews, Blood Pressure - Hypertension, Bone Density, JAMA, Kaiser Permanente, Osteoporosis, Pharmacology / 22.11.2016

MedicalResearch.com Interview with: Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096 MedicalResearch.com: What is the background for this study? Response: Hypertension (HTN) and osteoporosis (OP) are age-related disorders. Both increase rapidly in prevalence after age 65 years. Prior retrospective, post hoc studies have suggested that thiazide diuretics may decrease the risk of osteoporosis. These studies, by their nature, are open to bias. Moreover, these studies have not examined the effects of other anti HTN medications on osteoporosis. Here we used a prospective blood pressure study of ~5 years duration to examine the effects of a thiazide diuretic, a calcium channel blocker and an ACE inhibitor on hip and pelvic fractures. We chose these fractures since they are almost always associated with hospitalization and thus their occurrence can be verified. After the conclusion of the study we added another several years of follow up by querying medicare data sets for hip and pelvic fractures in those participants with medicare coverage after the study conclusion. (more…)
Author Interviews, Endocrinology, Hormone Therapy, JCEM, Menopause, Osteoporosis / 20.11.2016

MedicalResearch.com Interview with: Dr Georgios Papadakis FMH, Médecin InternenMédecin assistant Service d'endocrinologie, diabétologie et métabolisme Lausanne MedicalResearch.com: What is the background for this study? Response: This study was mainly motivated by the absence of available data on the effect of menopausal hormone therapy (MHT) on bone microarchitecture, as well as contradictory results of previous trials regarding the persistence of a residual effect after MHT withdrawal. We performed a cross-sectional analysis of 1279 postmenopausal women aged 50-80 years participating in OsteoLaus cohort of Lausanne University Hospital. Participants had bone mineral density (BMD) measurement by dual X-ray absorptiometry (DXA) at lumbar spine, femoral neck and total hip, as well as assessment of trabecular bone score (TBS), a textural index that evaluates pixel grey-level variations in the lumbar spine DXA image, providing an indirect index of trabecular microarchitecture. (more…)
Author Interviews, Endocrinology, Menopause, Osteoporosis / 27.10.2016

MedicalResearch.com Interview with: Pauline Camacho, MD, FACE Professor, Endocrinology Director, Loyola University Osteoporosis and Metabolic Bone Disease Center, Fellowship Program Director, Endocrinology, Medical Director, Osteoporosis Center MedicalResearch.com: What is the background for this report? What is the prevalence and significance of osteoporosis in US women? Response: Osteoporosis is widely prevalent and is increasing in prevalence not only in the US but also around the world. 10.2 million Americans have osteoporosis and that an additional 43.4 million have low bone mass. More than 2 million osteoporosis-related fractures occur annually in the US, more than 70% of these occur in women ( from National Osteoporosis Foundation (NOF) estimates). (more…)
Author Interviews, Columbia, NEJM, Orthopedics, Osteoporosis / 21.09.2016

MedicalResearch.com Interview with: 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). (more…)
Author Interviews, Orthopedics, Osteoporosis / 20.04.2016

MedicalResearch.com Interview with: Professor Nicholas C W Harvey, MA MB BChir PhD FRCP Professor of Rheumatology and Clinical Epidemiology Honorary Consultant Rheumatologist MRC Lifecourse Epidemiology Unit University of Southampton Southampton General Hospital Southampton UK MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Harvey:  It is well established that fracture risk is substantially increased by having had a previous fracture. A previous study suggested that fracture risk soon after a spine fracture might be greater than the risk later on, and if the risk varies with time, it would be sensible to identify the time at greatest risk, so intervention can be given. The risk of a second osteoporotic fracture was greatest immediately after the first fracture and thereafter decreased with time though remained higher than the population risk throughout follow up. For example, 1 year after the first fracture the risk of a second fracture was three times higher than the population risk. After 10 years it was two times higher. (more…)