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MEDS eNews





Vol. 3 No. 16
Goal-directed treatment backed

as ’next level’ for osteoporosis

SOUTHBURY, CONN. – An expert on osteoporosis says the goal-directed treatment approach presented in a recent report may boost care "to the next level" following what he calls a "decline" in attention to the disease.

Rick Pope, physician assistant (PA)-C, Department of Rheumatology, Western Connecticut Medical Group, Danbury, Conn., has high hopes for the efforts of the working group formed by the American Society for Bone and Mineral Research (ASMBR) and the United States National Osteoporosis Foundation (NOF).

The group’s progress report published in December by the Journal of Bone and Mineral Research defines goal-directed treatment as a strategy in which:

  • treatment goals are established for patients
  • initial treatment choices are based on the probability of reaching goals
  • progress towards reaching goals is reassessed periodically
  • the overriding treatment goal is to achieve freedom from fracture or at least low-fracture risk

Treatment goals include:

  • t-scores of more than minus 2.5
  • achievement of an estimated risk level below the threshold for initiating treatment

Pope, a Southbury, Conn., resident, founder and past three-time president of the Society of Physician Assistants in Rheumatology (SPAR), and faculty member of the Metabolic & Endocrine Disease Summit (MEDS), points to expectations for two drugs that could hit the market this year as among his reasons for optimism.

One, from Radius Health, is abaloparatide-SC 80 mcg, an investigational, once-daily treatment for post-menopausal women with osteoporosis; if approved by the U.S. Federal Drug Administration (FDA), it would be the first new bone-anabolic treatment option in the U.S. since 2002 for post-menopausal women with osteoporosis; a New Drug Application (NDA) was submitted last year.

Also: Amgen and UCB last year announced that the FDA accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. Romosozumab---for which the FDA has set a Prescription Drug User Fee Act (PDUFA) target-action date of July 19---works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

"The recommendations in this [working-group] report," says Pope, "would make goals more targeted, with levels of osteoporosis treatment based on bone mineral density (BMD). The report can make significant headway in treatments and approaches that are user-friendly, especially for primary care."

The report notes that goal-directed treatment can’t be fully achieved without medications that provide greater BMD increases and greater fracture-risk reductions.

Pope says a goal-directed approach will benefit patients of PAs and nurse practitioners (NPs) once the new approach becomes a reality, possibly during the next three years.

"The direction," he says "is to give practitioners a more specific end-point for management. The patient is directed to a number on a bone-density machine. With that goal in mind treatment is started or a change in treatment is recommended. It will be easier to set and reach goals in many cases, which is not currently being done, as goals are fuzzy, and BMD maintenance and some measure of improvement is recommended."


The report, Pope says, "is driven by data from studies, using large meta-data analysis to come up with conclusions. Meta-data analysis can be tricky. Studies are done with different end-points and populations, and conclusions may not be as specific as we like."


Pope echoes the report’s cautionary note that treatment selection is often based on or constrained by payer-reimbursement policies.


"Costs," he says, "will be closely calculated by insurance companies, and numbers needed to prevent fractures will be carefully estimated. If patients undertake any form of therapy, overall benefits will need to be shown as compared to the cost of care for hip fractures, spinal fractures and other incident fractures. An arduous task."


He underscores this emphasis by noting that "the most-costly, and most deadly, fracture is the hip fracture."


A goal-directed approach, Pope concludes, "can take osteoporosis treatment to the next level, getting to goals that will be verified and validated with newer and more potent medications that will be achievable for most."


"This is a large undertaking," he says, "and I applaud it. It will and should go this next step however better pharmaceuticals and more aggressive regimens are needed to make an important and recognizable difference in the osteoporosis population."

CITATION: Steven R. Cummings, Felicia Cosman, et. al. Goal-Directed Treatment for Osteoporosis: A Progress Report From the ASBMR-NOF Working Group on Goal-Directed Treatment for Osteoporosis. Journal of Bone and Mineral Research. First published 27 December 2016. Volume 32, Issue 1. January 2017. Pages 3-10.

Diabetic retinopathy targeted

in recommendations from ADA

BALTIMORE – A recent American Diabetes Association (ADA) position statement cites studies showing the positive effects tight glycemic control can have on diabetic retinopathy risks and progressions in patients with diabetes, and how those benefits can last for years.

The statement published in March in Diabetes Care outlines the stages of diabetic retinopathy and highlights recommendations on optimal blood-glycemic control and lowering blood pressure.

Its authors---including Sharon D. Solomon, Johns Hopkins Medicine, Baltimore, and Emily Chew, National Institutes of Health, Bethesda, Md.---also include screening recommendations suggesting that adults with type 1 diabetes receive comprehensive eye exams within five years of the onset of diabetes, and that those with type 2 diabetes have exams at time of diagnosis.

If there is no evidence of retinopathy for one or more annual eye exams, the statement indicates, exams every two years may be considered.

They also recommend that women with pre-existing type 1 or type 2 diabetes who are pregnant or planning to become pregnant be counseled on the risks of development and/or progression of diabetic retinopathy.

If any level of diabetic retinopathy is present, subsequent dilated retinal examinations for patients with type 1 or type 2 diabetes should be repeated at least annually by an ophthalmologist or optometrist; if retinopathy is progressing or sight-threatening, examinations will be required more frequently.

Treatment recommendations include:

  • prompt referral of patients with any level of macular edema; severe non-proliferative diabetic retinopathy (a precursor of proliferative diabetic retinopathy); or any proliferative diabetic retinopathy to an ophthalmologist who is knowledgeable and experienced in management and treatment of diabetic retinopathy
  • laser photocoagulation therapy reduces vision-loss risk in patients with high-risk proliferative diabetic retinopathy and, in some cases, severe non-proliferative diabetic retinopathy
  • intravitreous injections of anti-vascular endothelial growth factor are indicated for central-involved diabetic macular edema (DME)
  • while optimization of blood glucose, blood pressure, and serum lipid levels in conjunction with dilated eye examinations can substantially decrease the vision-loss risk from complications of diabetic retinopathy, a significant proportion of those affected with diabetes develop DME or proliferative changes requiring intervention


CITATION: Sharon D. Solomon, Emily Chew, et. al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. March 2017.

Research: High-protein diet won’t

significantly affect FFM changes

AMSTERDAM – A high-protein diet, though lower than targeted, does not significantly affect changes in fat-free mass (FFM) during modest weight loss in older overweight and obese adults, according to a study published in February in the Nutrition Journal.

Its authors---including Amely M. Verreijen and Mariélle F. Engberink, Amsterdam University of Applied Sciences, Amsterdam---also indicate that there is no significant interaction between the high-protein diet and resistance exercise for change in FFM.

The researchers, who investigated whether a high-protein diet and/or resistance exercise preserves FFM during weight loss among overweight and obese adults, determined that only the studied group with a combined intervention of high-protein diet and resistance exercise significantly increased in FFM.

This suggests that combining protein with resistance exercise is beneficial for FFM preservation during weight loss for older adults; the researchers add that this point should be confirmed by future studies using a larger protein contrast.

The authors, noting that intentional weight loss in older obese adults is a risk factor for accelerated muscle-mass loss, assessed 100 overweight and obese adults, aged 55-to-80 years-of-age, in a randomized controlled trial (RCT) with a two-by-two factorial design and intention-to-treat analysis.

All subjects followed a hypocaloric diet during a 10-week weight-loss program; subjects were randomly allocated to either a high- or normal-protein diet, with-or-without a resistance-exercise program three times a week. FFM was assessed by air-displacement plethysmography.

Both high-protein diet and exercise did not significantly affect change in body weight, FFM and fat mass (FM).

No significant protein-exercise interaction effect was observed for FFM, although within-group analysis showed that high protein in combination with exercise significantly increased FFM.

Also: A March research letter in the Journal of American Medicine reports on a study of adults who were overweight or obese and trying to lose weight during three periods from 1988 through 2014. The letter---which can be accessed at that a growing number of such adults are not trying to loss excess weight.

CITATION: Amely M. Verreijen, Mariélle F. Engberink, et. al. Effect of a high protein diet and/or resistance exercise on the preservation of fat free mass during weight loss in overweight and obese older adults: a randomized controlled trial. Nutrition Journal. Received: 19 October 2016. Accepted: 16 January 2017. Published: 6 February 2017.

Novel assay targets benign,

malignant thyroid nodules

REHOVOT, ISRAEL – A novel assay utilizing microRNA expression in cytology smears is the subject of benign-and-malignant thyroid-nodule research published in February in the Journal of Clinical Pathology.

Its authors---including Gila Lithwick-and Nir Dromi, of Rosetta Genomics Ltd., Rehovot, Israel---note that the assay distinguishes benign from malignant thyroid nodules using a single fine-needle aspirate (FNA)-stained smear, and does not require fresh tissue or special collection-and-shipment conditions.

The assay offers a tool for the pre-operative classification of thyroid samples with indeterminate cytology.

The researchers present a new diagnostic assay and evaluate its performance on a blinded set of 189 samples from several sources.

The test described in the paper is a multi-center, clinically-evaluated, commercially-available assay that can accurately differentiate between malignant-and-benign thyroid nodules using routinely-prepared FNA-stained smears.

A training set of 375 FNA smears was used to develop the microRNA-based assay, which was validated with a blinded, multi-center, retrospective cohort of 201 smears.

Validation samples were from adult patients at least 18 years of age with nodule sizes of more than 0.5 cm, and a final diagnosis confirmed by at least one of two blinded, independent pathologists.

Take-home messages include:

  • 10%-to-40% of thyroid FNAs are not conclusively diagnosed by cytology and are categorized as indeterminate
  • the RosettaGX Reveal assay, which was blindly validated, differentiates benign from malignant thyroid nodules in indeterminate smears
  • smear used for the assay can be a routinely-prepared smear used to make the indeterminate diagnosis, and does not require a repeat FNA
  • the assay does not require fresh tissue or special collection and shipment conditions
CITATION: Gila Lithwick-Yanai, Nir Dromi, et. al. Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears. Journal of Clinical Pathology. 02/06/2017.;
Harmonized-reference ranges

are assessed for testosterone

BOSTON – A recent study indicates that a substantial proportion of inter-cohort variation in testosterone levels is due to assay differences.

Data in the study published in January in The Journal of Clinical Endocrinology & Metabolism demonstrates the feasibility of generating harmonized-reference ranges for testosterone that can be applied to assays, which have been calibrated to a reference method and calibrator.

The study---whose authors include Thomas G. Travison, Harvard Medical School, Boston, and Hubert W. Vesper, Centers for Disease Control and Prevention, Atlanta---indicates that the harmonized-normal range in the non-obese population of European and American men aged 19-to-39 years is 264-to-916 ng/dL.

The researchers note that reference ranges for testosterone are essential for making a diagnosis of hypogonadism in men and set out to establish harmonized-reference ranges for total testosterone that can be applied across laboratories by cross-calibrating cohort-specific assays to a reference method and standard.

The research included 9,054 community-dwelling men in cohort studies in the United States and Europe from: Framingham Heart Study; European Male Aging Study; Osteoporotic Fractures in Men Study; Male Sibling Study of Osteoporosis.

Testosterone concentrations in 100 participants in each of the four cohorts were measured using a reference method from the Centers for Disease Control (CDC). Generalized-additive models and Bland-Altman analyses supported the use of normalizing equations for transformation between cohort-specific and CDC values.

And in a related matter: An editorial published in February by the Journal of the American Medical Association assesses testosterone and male aging. It can be accessed at

CITATION: Thomas G. Travison, Hubert W. Vesper, et. al. Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the USA and Europe. The Journal of Clinical Endocrinology & Metabolism. Published: 10 January 2017.
Clinician Reviews addresses

issue of vitamin D’s role in MS

A March article in Clinician Reviews assesses the role of vitamin D in multiple sclerosis (MS). Written by Lisa Marie Fox, MSPAS, PA-C, who is affiliated with Johns Hopkins Hospital in Baltimore, the piece notes that living farther from the equator, not being exposed to sunlight, and having a low vitamin D level are correlated with increased risk for MS and MS relapse. The article---which can be accessed at that, in light of the anti-inflammatory effects of vitamin D and its purported reduction of MS risk, it is possible that MS patients should start vitamin D supplementation early in order to obtain maximum anti-inflammatory effects.


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