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 include:
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. http://onlinelibrary.wiley.com/doi/10.1002/jbmr.3039/full