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Vol. 3 No. 22

A note of caution is sounded
for vitamin D self-diagnosing

LAGUNA NIGUEL, CALIF. – Recently-published research indicating increased excessive use of vitamin D dietary supplements doesn’t surprise the president of the American Society of Endocrine Physician Assistants (ASEPA).

Ji Hyun Chun, PA-C, BC-ADM, OptumCare Medical Group, Laguna Niguel, Calif., and a faculty member of Metabolic & Disease Summit (MEDS), commented recently on a   research letter published in June by JAMA citing a study on high-dose vitamin D supplement use.

The study utilizing the National Health and Nutrition Examination Survey (NHANES) that data from 1999-through-2014 shows that 3% of the U.S. population exceeds the daily upper limit of 4,000 international units (IUs). Such use could pose a risk of adverse effects including high calcium levels in the blood, soft tissue, and vascular calcification.

The researchers used data from 39,243 NHANES participants to assess daily supplemental vitamin D use of 1,000 IU or more and 4,000 IU or more.

Their data indicated that the prevalence of daily supplemental vitamin D use of 1,000 IU or more in 2013-to-2014 was 18.2%, up from 0.3% in 1999-to-2000. They also found that the prevalence of daily supplemental intake of 4,000 IU or more in 2013-to-2014 was 3.2%, up from less than 0.1% before 2005-to-2006.

Trends of increasing supplemental vitamin D use were found for most age groups, race/ethnicities, and both sexes.

From 2013-to-2014, intake of 4,000 IU or more daily was highest among women, non-Hispanic white people, and those 70-years-or older.
These overall results of this research are not eye-opening for Chun, who notes that self-medication is likely behind the trend.

“There was a period of time when vitamin D was a ‘hot topic’ and drew media attention,” Chun says, “essentially linking all conditions with vitamin D deficiency, though bone health is so far the only condition with hard data.

This has led to an increased intake of vitamin D supplements by the general population without recommendation from their healthcare providers.”

Chun doubts that all who take these supplements are aware of the dangers of over-use, or the risks of self-medication.

“Most common misconception in public is,” he says, “the notion that if low is bad, high must be good, or vice versa. They need to be informed and reminded that vitamin D levels can reach toxic (harmful) level with too much ingestion. Using more than 4,000 IU/day should be only done in recommendation of a provider and levels need to be monitored in such cases. These will be in patients with known frank deficiency with underlying cause (i.e., malabsorption, medication hyper metabolizing vitamin D)”

PAs and nurse practitioners (NPs), says Chun, should “encourage patients to bring in their medications so we can look at what they are taking, both prescription and over-the-counter.

“People should not start taking high dose vitamin D supplements without first seeing a medical person,” Chun concludes. “They should not be self-diagnosing.”


CITATION: Mary R. Rooney, MPH; Lisa Harnack, DrPH, RD, et. al. Trends in Use of High-Dose Vitamin D Supplements Exceeding 1000 or 4000 International Units Daily, 1999-2014. JAMA. 2017;317(23):2448-2450.
Increase in use of high-dose vitamin D supplements. Science Daily. June 20, 2017.


DKA, type 2 diabetes linked
to anti-psychotic exposure

AALBORG, DENMARK – Anti-psychotic exposure is associated with diabetic ketoacidosis (DKA) and type 2 diabetes in a previously diabetes-naive schizophrenia population, according to a recent study indicating that anti-psychotic-associated DKA is relevant not only for psychiatrists but also for other physicians who may manage and admit such patients.

The study published in September in Diabetologia was designed to investigate associations between exposure to anti-psychotic medication within three months before event and DKA, type 1 diabetes, and type 2 diabetes.

Its authors---including Christoffer Polcwiartek and Kristian Kragholm, Aalborg University Hospital, Aalborg, Denmark---noted that DKA is a potentially-fatal metabolic emergency of both type 1 and type 2 diabetes, and that while there is reduced risk of type 1 diabetes in schizophrenia, DKA incidence is 10-fold higher than that of the general population.

The researchers used a nested case-control study design and identified DKA cases, type 1 diabetes, and type 2 diabetes in a previously diabetes-naive population with schizophrenia in Denmark from 1995-to-2014.

Cases were matched 1:5 to schizophrenic-control individuals who were alive and had not emigrated prior to event. Conditional-logistic regression was used to compute odds ratios (ORs) with 95% confidence intervals (CIs).

Other outcomes included diabetes aetiology of DKA; in-hospital mortality; DKA re-admissions; and temporal trends of use of insulin and oral glucose-lowering agents.

Of 29,955 individuals with schizophrenia, 28 were identified with DKA, 90 with type 1 diabetes, and 2,140 with type 2 diabetes. These were matched to 137,410 and 9,861 individuals in the control group, respectively.

Anti-psychotic exposure was associated with DKA and type 2 diabetes. A trend towards increased risk of type 1 diabetes was found, but remained insignificant.

Diabetes aetiology of DKA was type 1 in eight cases and type 2 in 14. Of the remaining six DKA cases, aetiology couldn’t be determined, as four were fatal within eight days, and for two, no prescriptions for insulin and oral glucose-lowering agents were redeemed.

Of all DKA cases, six had more than one DKA episode, and of all type 1 diabetes and type 2 diabetes cases, four and 11, respectively, had at least one.

CITATION: Christoffer Polcwiartek, Kristian Kragholm, et. al. Diabetic ketoacidosis and diabetes associated with antipsychotic exposure among a previously diabetes-naive population with schizophrenia: a nationwide nested case–control study. Diabetologia. September 2017, Volume 60, Issue 9. pp 1678-1690. First online: 07 June 2017.


Weight challenges associated
with absenteeism from school

CHAMPAIGN, IL. – A recent meta-analysis indicates that the odds of being absent from school are 27% and 54% higher among children with overweight and obesity than among their normal weight counterparts, respectively.

The research published in September in Obesity Reviews---whose authors include Huimin Yan, University of Illinois at Urbana-Champaign, Champaign, IL.---also indicates that future studies should adopt an experimental-study design and accurate measures on school attendance, and delineate the underlining pathways linking childhood obesity to school absenteeism through obesity-related illnesses and psycho-social problems

The authors noted that regular school attendance is a key determinant of students’ academic achievement and psycho-social development, and that obesity may affect school attendance through its detrimental impact on physical and mental health.

A literature search was conducted in the PubMed, Web of Science and Cochrane Library for articles published until April 2017 examining the relationship between unhealthy body weight and school absenteeism among children and adolescents.

A total of 13 studies (10 cross-sectional and three longitudinal) were identified; mean-and-median sample sizes were 24,861 and 3,113, respectively.

Ten studies objectively measured children's height and weight, and three were based on parents' self-reporting. Four studies measured absenteeism using school administrative data, and nine administered questionnaires to children's parents.

Eleven of the studies reported a statistically-significant positive association between childhood overweight/obesity and school absence; two reported null effect.


CITATION: An R, Yan H, et. al. Childhood obesity and school absenteeism: a systematic review and meta-analysis. Obesity Reviews. Version of record online: 18 September 2017. Manuscript accepted: 13 July 2017. Manuscript revised: 11 July 2017. Manuscript received: 23 April 2017.


Elevated TSH, FT4, reduced T3
tied to kidney-function issues

FREIBURG, GERMANY – Elevated thyroid-stimulating hormone (TSH), free thyroxine (FT4) and reduced triiodothyronine (T3) concentrations are associated with reduced kidney function cross-sectionally, according to a recent study indicating that the lack of association with the development of incident chronic kidney disease (CKD) suggests that altered thyroid function in the general population is not causally related to CKD development.

The study published in November in Nephrology Dialysis Transplantation also indicates that thyroidal-status screening may be especially relevant in persons with reduced kidney function.

Its authors---including Ulla T Schultheiss, University of Freiburg, Freiburg, Germany, and Natalie Daya, Johns Hopkins Bloomberg School of Public Health, Baltimore---quantified concentrations of TSH, FT4, T3 and thyroid peroxidase antibody (TPOAb) in 12,785 black and white participants of the ongoing community-based prospective Atherosclerosis Risk in Communities Study (ARIC).

Thyroid markers and clinical categories of thyroid dysfunction (euthyroidism, combined sub-clinical and overt hypothyroidism, combined sub-clinical and overt hyperthyroidism) were evaluated for their association with reduced kidney function (estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m2) at study baseline and with incident CKD over a median follow-up time of 19.6 years.

Higher TSH and FT4 as well as lower T3 concentrations were strongly and independently associated with reduced kidney function at study baseline. The clinical entities hypothyroidism and hyperthyroidism were also associated with higher odds of baseline reduced kidney function, but this was not significant.

However, none of the markers of thyroid function nor different clinical categories of thyroid dysfunction (hypothyroidism, hyperthyroidism or TPOAb positivity) were associated with incident CKD in adjusted analyses.

CITATION: Ulla T Schultheiss, Natalie Daya, et. al. Thyroid function, reduced kidney function and incident chronic kidney disease in a community-based population: the Atherosclerosis Risk in Communities study. Nephrology Dialysis Transplantation, Volume 32, Issue 11, 1 November 2017, Pages 1874–1881.


Study: OST is somewhat better
than FRAX for BMD selection

MINNEAPOLIS – The Osteoporosis Self-Assessment Tool (OST) performs modestly better than the more-complex Fracture Risk Assessment Tool (FRAX) in selecting older men for bone-mineral density (BMD) testing to screen for osteoporosis, according to a study published in November in the Journal of General Internal Medicine.

Its authors---including Susan J. Diem, University of Minnesota---found that using either tool substantially reduces the proportion of men referred for BMD testing compared to universal screening.

Their research also indicates that of 1,000 men aged 70-and-older in a community-based cohort, the use of an OST cut-off of under two to select BMD testing would result in 654 men referred for BMD testing, of whom 44 would be identified as having osteoporosis, with nine missed who have osteoporosis.

Participants included 4,043 community-dwelling men; main measures in the study included BMD at the total hip, femoral neck, and lumbar spine, using dual-energy X-ray absorptiometry (DXA).

Among the cohort, 216 had BMD T-scores of minus 2.5 or less at the femoral neck, total hip, or lumbar spine, and 1,184 met criteria for consideration of pharmacologic therapy according to National Osteoporosis Foundation (NOF) guidelines.

The OST had better discrimination than the FRAX for identifying T-score-defined osteoporosis.

The use of an OST threshold of less than two resulted in sensitivity of 0.83 and specificity of 0.36 for the identification of osteoporosis, compared to sensitivity of 0.59 and specificity of 0.59 for the use of FRAX with a cut-off of 9.3% 10-year risk of major osteoporotic fracture.

CITATION: Susan J. Diem, Katherine W. Peters, et. al. Screening for Osteoporosis in Older Men: Operating Characteristics of Proposed Strategies for Selecting Men for BMD Testing. Journal of General Internal Medicine. November 2017, Volume 32, Issue 11, pp 1235-1241.


Insulin-pump therapy matters
detailed in Clinician Reviews

Insulin-pump therapy is addressed in a Q&A article in Clinician Reviews in November. Written by Alyssa Kanagaki Greenleaf, Baystate Endocrinology and Diabetes, Springfield, Mass., the article notes that diabetes management has moved beyond metformin, with one advance being that of insulin pumps, which enhance or mimic the role of the pancreas. Issues addressed include use of the pumps, ideal candidates, advances, therapy initiation, and insurance. The article can be accessed at


Vol. 3 No. 21


Diabetes professionals ‘reeling’
from recent meds-CVD research

DETROIT – The importance of health-care providers communicating cardiovascular issues to diabetes patients can’t be over-estimated---especially with recent treatment developments.

“We need to communicate to patients that we now have medications with the potential to provide cardiovascular benefits,” says Davida F. Kruger, a certified nurse practitioner (NP) in diabetes at Henry Ford Health System’s Division of Endocrinology, Diabetes, Bone and Mineral Disease, Detroit.

Kruger, a faculty member of Metabolic & Endocrine Disease Summit (MEDS) and American Diabetes Association (ADA) 2017 educator of the year, notes that while patients hear about new medications from television commercials, from articles in print and online, it is important that their health-care providers be knowledgeable and explain these medications and their benefits to their patients, both in terms of lowering A1C and in their potential cardiovascular benefits.

“We need to talk,” says Kruger, “with patients about the fact that the risks of diabetes complications include cardiovascular disease, and that some of these (newer) medications lower blood glucose and A1C, and also have some protection in terms of cardiovascular outcomes, and the importance of selecting drugs for patients at risk for cardiovascular complications. That there are drugs that might also provide cardiovascular benefits.”

An article published in October in The Nurse Practitioner, co-authored by Kruger, addresses sodium-glucose cotransporter-2 (SGLT2) inhibitors and their potential benefits for type 2 diabetes mellitus (T2DM) patients at high cardiovascular disease (CVD) risk who already take multiple medications.

The article lists two such medications approved in the United States---canagliflozin and empagliflozin---and makes the following points in setting patient expectations:  

  • it is important that patients understand what percentage increase in A1C can be expected from these medications
  • SGLT2 clinical trials report A1C decreases from -0.5% to 1.5% when used as monotherapy
  • if patients are treatment-naïve or have higher-baseline A1C values, reductions may be larger than observed in clinical trials
  • patients should be warned to expect urine-volume increases as they initiate therapy and maintain adequate hydration levels

The road to diabetes medications addressing CVD issues was repaved in 2008, when the U.S. Food & Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all anti-diabetic drugs to be licensed in the future. The agency recommended that when drugs are developed for glycemic management of type 2 diabetes, it be shown that these medications do not increase the risk of cardiovascular events over placebo levels.

“New drugs,” Kruger explains, “must be shown to be equal to placebos, to cause no more harm than placebos, to show no increase in myocardial infarctions, sudden death or stroke.” These three issues comprise three-point primary major adverse cardiac events (MACE)---cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke.

Empagliflozin treatment, as noted in The Nurse Practitioner article, was found in secondary analysis to result in a 38% relative risk reduction (RRR) in cardiovascular death and improved overall survival with a 32% RRR in all-cause mortality. Data from the EMPAG-REG OUTCOME study lists it as the first of the recently-approved glucose-lowering agents to significantly reduce cardiovascular-mortality risk among T2DM patients with pre-existing CVD.

Canagliflozin treatment, as noted in a study published in August in the New England Journal of Medicine (NEJM), reporting on two recent CANVAS, or CANagliflozin CardioVascular Assessment Study, trials, resulted in lower risks of cardiovascular events than for patients receiving placebos---with greater amputation risk.

The increased amputation risk, as reported in the NEJM article, was 6.3 versus 3.4 participants per 1,000 patient-years, with hazard ratio, 1.97; 95% confidence interval (CI), 1.41 to 2.75; amputations were primarily at the level of the toe or metatarsal.

The Nurse Practitioner article adds that trials for dapagliflozin indicate that rates of genital mycotic infections (GMIs) are higher with this drug than placebos.

Another recent article in the same publication, addressing dipeptidyl peptidase-4 (DPP4) inhibitors, lists four drugs approved for U.S. use for T2DM patients: saxagliptin and alogliptin (with warnings that patients taking these should be monitored for heart failure), linagliptin, and sitagliptin (for which the ADA this year notes has neutral effects on cardiovascular risk and raises no significant safety concerns among older patients with well-controlled type 2 diabetes and CVD).

Lastly, a study published in August in NEJM addresses treatment for type 2 diabetes patients at high cardiovascular risk with liraglutide and indicates lower diabetic-kidney disease rates than placebo; the study also notes that liraglutide resulted in lower risks of the primary end point (non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes) and death.

“We are reeling,” Kruger concludes, from the succession of drugs being developed and researched for those battling diabetes coupled with CVD.

CITATION: Novak, Lucia M. MSN, ANP-BC, BC-ADM, CDTC; Kruger, Davida F. MSN, APN-BC, BC-ADM. Bolstering your armamentarium with SGLT2 inhibitors. The Nurse Practitioner. 18 October, 2017. Volume 42, Issue 10, P. 28-34.  Bernard Zinman, M.D., Christoph Wanner, M.D., et. al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. The New England Journal of Medicine. November 26, 2015.
Bittle, Polly A. MSN, ARNP, FNP-C. The use of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes & chronic kidney disease. The Nurse Practitioner. 16 June 2017. Volume 42, Issue 6. P. 31-37.
Bruce Neal, M.B., Ch.B., Ph.D., Vlado Perkovic, M.B., B.S., Ph.D., et. al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. The New England Journal of Medicine. August 17, 2017.
Johannes F.E. Mann, M.D., David D. Ørsted, M.D., Ph.D. et. al. Liraglutide and Renal Outcomes in Type 2 Diabetes. The New England Journal of Medicine. August 31, 2017. 377:839-848.
(Funded by Novo Nordisk and the National Institutes of Health; LEADER number, NCT01179048.) Anthony A. Bavry, M.D., M.P.H., FACC. Canagliflozin Cardiovascular Assessment Study – CANVAS. American College of Cardiology. August 22, 2017. Oliver Schnell , Lars Rydén, et. al. Current perspectives on cardiovascular outcome trials in diabetes. Cardiovascular Diabetology. 2016. 15:139. 1 October 2016.



Prevalence of obesity at 39.8%
among adults in United States

ATLANTA – Obesity prevalence was 39.8% among adults and 18.5% among youths in the United States in 2015-to-2016, according to information released by the Centers for Disease Control and Prevention (CDC).

Key points in data released in October by the Atlanta-based CDC and obtained from the National Health and Nutrition Examination Survey (NHANES), include:

  • obesity prevalence increased in adults and youths between 1999-to-2000 and 2015-to-2016
  • prevalence of obesity was higher among middle-aged adults (42.8%) than among younger adults (35.7%)
  • prevalence of obesity was higher among youths aged six-to-11 years (18.4%) and adolescents aged 12-to-19 (20.6%) compared with children aged two-to-five years (13.9%)
  • overall prevalence of obesity was higher among non-Hispanic black and Hispanic adults than among non-Hispanic white and non-Hispanic Asian adults, with the same pattern seen among youths
  • the observed change in prevalence between 2013-to-2014 and 2015-to-2016 was not significant among both adults and youth
  • women had a higher prevalence of obesity than men among non-Hispanic black, non-Hispanic Asian, and Hispanic adults, but not among non-Hispanic white adults
  • prevalence of obesity in the United States remains higher than the Healthy People 2020 goals of 14.5% among youths and 30.5% among adults

The study’s lead author, Craig M. Hales, a CDC medical epidemiologist, told CNN that since 1999, there has been a major increase in obesity prevalence, especially among adults, without any “signs of it slowing down.”

Hale adds that while youth obesity rates seemed to have stabilized in recent years, it is “too early to tell” what direction obesity in this demographic will take, as at least four more years of data are needed to gauge the direction.

CITATION: Craig M. Hales, M.D., Margaret D. Carroll, M.S.P.H., et. al. Prevalence of Obesity Among Adults and Youth: United States, 2015–2016. Centers for Disease Control and Prevention. NCHS Data Brief No. 288, October 2017.



Cardiovascular, mortality benefits said
to outweigh CKD risks of SBP-lowering

SALT LAKE CITY – Intensive systolic blood pressure (SBP)-lowering increases the risk of incident chronic kidney disease (CKD) events, according to a study published recently by the Annals of Internal Medicine also indicating that this is outweighed by cardiovascular and all-cause mortality benefits.

Authors of the study published in September and primarily funded by the National Institutes of Health (NIH) include Srinivasan Beddhu, University of Utah School of Medicine, Salt Lake City, and Michael V. Rocco, who practices medicine in Winston-Salem, N.C.

The researchers set out to examine the effects of intensive SBP lowering on kidney-and-cardiovascular outcomes and contrast its apparent beneficial-and-adverse effects.

They assessed 6,662 adults with high blood pressure and elevated cardiovascular risk, randomly assigned to an intensive or standard SBP goal (120 or 140 mm Hg, respectively).

Measurements included:

  • differences in mean estimated glomerular filtration rate (eGFR) during follow-up (estimated with a linear mixed-effects model)
  • pre-specified incident CKD (defined as a decrease of more than 30% in eGFR to a value of less than 60 mL/min/1.73 m2)
  • a composite of all-cause death or cardiovascular event, with surveillance every three months

The difference in adjusted mean eGFR between the intensive and standard groups was − 3.32 mL/min/1.73 m2 (95% CI, −3.90 to −2.74 mL/min/1.73 m2) at six months; − 4.50 mL/min/1.73 m2 (CI, −5.16 to −3.85 mL/min/1.73 m2) at 18 months; and remained relatively stable thereafter.

An incident CKD event occurred in 3.7% of participants in the intensive group and 1.0% in the standard group at three-year follow-up, with a hazard ratio of 3.54 (CI, 2.50 to 5.02).

The corresponding percentages for the composite of death or cardiovascular event were 4.9% and 7.1% at three-year follow-up, with a hazard ratio of 0.71 (CI, 0.59 to 0.86).

The researchers noted the limitation of a lack of long-term data.

CITATION: Srinivasan Beddhu, MD, Michael V. Rocco, MD, MSCE, et. al.
Effects of Intensive Systolic Blood Pressure Control on Kidney and Cardiovascular Outcomes in Persons Without Kidney Disease: A Secondary Analysis of a Randomized Trial. Annals of Internal Medicine. ORIGINAL RESEARCH |19 SEPTEMBER 2017.



Pre-term infants’ improvements
linked to 800-IU vitamin-D doses

OMAHA, NEB. – A recent study indicates that improvements in 25(OH)D3 levels at four weeks, bone density, and trends towards improvement in linear growth support consideration of daily vitamin-D doses of 800 international units (IUs) for infants younger than 32 weeks in neonatal intensive care units (NICUs).

The study published in October in PLoS ONE was designed to evaluate serum 25(OH)D3 concentration changes after four weeks in response to two different doses of vitamin D3 supplementation in a population of premature infants, and quantify the impact on NICU outcomes.

Its authors---including Ann Anderson-Berry, University of Nebraska Medical Center, Omaha, Neb.---prospectively randomized 32 infants born at 24-to-32 weeks gestation to receive 400 or 800 IU/day vitamin D3 supplementation.

Serum 25(OH)D3 levels were measured every four weeks. The Wilcoxon signed rank test was used to compare serum levels of 25(OH)D3 at four weeks and each subsequent time point; a p-value of less than 0.05 was considered statistically- significant.

Serum 25(OH)D3 levels at birth were 41.9 and 42.9 nmol/l for infants in the 400 IU group and 800 IU group, respectively. Cord 25(OH)D3 concentrations significantly correlated with gestational age.

After four weeks of D3 supplementation, median 25(OH)D3 levels increased in both groups. Infants in the 400 IU group were significantly more likely to have dual energy X-ray absorptiometry (DEXA) bone-density measurements less than 10 percentile.

Vitamin D supplementation for pre-term and term neonates is recommended by such groups as the American Academy of Pediatrics (AAP); the Institute of Medicine (IOM), now the National Academy of Medicine (NAM); the Endocrine Society; and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).

Also: A study of vitamin D and hypertension published in September in Electrolytes and Blood Pressure---whose authors include Hye Yun Jeong, CHA University, South Korea---indicates that the results of randomized controlled trials (RCTs) and meta-analysis do not support the use of vitamin D or its analogues as an individual-patient treatment for hypertension or as a population-level intervention to lower blood pressure. The study can be accessed at

CITATION: Ann Anderson-Berry, Melissa Thoene, et al. Randomized trial of two doses of vitamin D3 in preterm infants <32 weeks: Dose impact on achieving desired serum 25(OH)D3 in a NICU population. PLoS ONE. 12(10): e0185950. Received: April 5, 2017. Accepted: September 23, 2017. Published: October 10, 2017.


Romosozumab boosted by study
involving post-menopausal women

BIRMINGHAM, ALA. – A study involving more than 4,000 subjects indicates that among post-menopausal women with osteoporosis at high-fracture risk, romosozumab treatment for 12 months followed by alendronate results in a significantly-lower fracture risk than alendronate alone.

Authors of the study published in October in the New England Journal of Medicine---including Kenneth G. Saag, UAB School of Medicine, Birmingham, Ala.---note that romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption.

The researchers enrolled 4,093 post-menopausal women with osteoporosis and a fragility fracture and randomly assigned them in a one-to-one ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups.

The primary-end points were the cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture (non-vertebral and symptomatic vertebral fracture) at the time of the primary analysis (after clinical fractures had been confirmed in at least 330 patients).

Secondary end points included the incidences of non-vertebral and hip fracture at the time of the primary analysis.

Over a period of 24 months, a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group than in the alendronate-to-alendronate group.

Clinical fractures occurred in 198 of 2,046 patients in the romosozumab-to-alendronate group versus 266 of 2,047 in the alendronate-to-alendronate group, representing a 27% lower risk with romosozumab.

The risk of non-vertebral fractures was lower by 19% in the romosozumab-to-alendronate group than in the alendronate-to-alendronate group, and the risk of hip fracture was lower by 38%.

Overall adverse events and serious adverse events were balanced between the two groups. During year one, positively-adjudicated serious cardiovascular adverse events were observed more often with romosozumab than with alendronate (50 of 2040 patients versus 38 of 2,014).

CITATION: Kenneth G. Saag, M.D., Jeffrey Petersen, M.D., et. al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. New England Journal of Medicine. 2017; 377:1417-1427. October 12, 2017. ARCH Clinical number, NCT01631214.


Positive troponin tests in CKD
explained in Clinician Reviews

An October Q & A in Clinician Reviews addresses the issue of patients with chronic kidney disease (CKD) sent to emergency departments (EDs) for chest pain or shortness of breath whose troponin levels are high. Marlene Shaw-Gallagher, MS, PA-C, University of Detroit Mercy, Detroit, explains that cardiac troponins are the gold standard for detecting myocardial injuries in patients presenting to EDs with suggestive symptoms, and that the reason for more positive troponin results in the CKD population is increased accuracy in newer tests and the fact that CKD often causes a false-positive result. The article can be accessed at


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