Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen)and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE).
"This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis," the authors say.
The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.
They also include a treatment algorithm to help guide choice of therapy.
Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.
While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.
"The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it," Pauline M. Camacho, MD, co-chair of the guidelines task force, told Medscape Medical News.
"We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria," said Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University, in Maywood, Illinois.
"It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?"
An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T-score or a fragility fracture, the guidelines state.
Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.
Specifically, patients should be consideredat a very high fracture risk if they have the following criteria: a recent fracture (eg, within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (eg, long-term glucocorticoids), very low T-score (eg, less than 3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (eg, major osteoporosis fracture > 30%, hip fracture > 4.5%) or other validated fracture risk algorithm.
Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.
Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.
The drug's approval by the US Food and Drug Administration (FDA) in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.
Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab compared to placebo and alendronate.
Camacho noted that romosozumab "will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide."
Romosozumab can safely be used in patients with prior radiation exposure, the guidelines note.
Importantly, due to reports of a higher risk of serious cardiovascular events with romosozumab compared to alendronate, romosozumab comes with a black box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.
"Unfortunately, the very high risk group is often the older patients,"Camacho notes.
"The drug should not be given if there is a history of myocardial infarction or stroke in the past year," she emphasized. "Clinical judgement is needed to decide who is at risk for cardiovascular complications."
Notably, teriparatide and abaloparatide have black box warnings of their own regardingrisk for osteosarcoma.
Reflecting the evolving data on osteoporosis drug holidays, the guidelines also address the issue and the clinical challenges of switching therapies.
"In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug," Camacho said.
For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.
The updated guidelines recommend that upon discontinuation of an anabolic agent (eg, abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.
Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.
Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.
The authors underscore that in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.
"It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns," they write.
And in estimating patients' fracture risk, T-score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.
"Treatment recommendations may be quite different; an early postmenopausal woman with a T-score of 2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T-score," the authors explain.
Camacho has reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.
AACE/ACE Guidelines 2020 Update. Full text
Follow Medscape on Facebook, Twitter, Instagram, and YouTube.
Read this article:
New Osteoporosis Recommendations From AACE Help Therapy Selection - Medscape
- Low T Therapy Market Size, Trends, Production, Demand and Profit Is Statistical Analyzed in 2021 Report: AbbVie, Endo International, Eli Lilly ... - January 24th, 2021
- Healthy Men: What women need to know about men's health - Greater Milwaukee Today - November 20th, 2020
- 24 Ways to Increase Penis Sensitivity: Tips, Techniques, and More - Healthline - October 18th, 2020
- Centrapeak Testosterone Booster Review: Is it Better than Others on the Market? - generationiron.com - October 18th, 2020
- Erectile Dysfunction: A Look at the Most Common Causes - Feed Leader - October 10th, 2020
- Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year - BioSpace - October 6th, 2020
- Aytu BioScience to Report Fourth Quarter and Full Year Fiscal 2020 Results and Provide Business Update on Tuesday, October 6, 2020 - Yahoo Finance - October 6th, 2020
- Whats Causing My Low Testosterone? - September 29th, 2020
- Indianapolis Low T Center & Men's Clinic | Sleep Apnea ... - September 29th, 2020
- Could This Device Help Save Covid-19 Patients Before the ICU? - Houstonia Magazine - September 6th, 2020
- Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study - Yahoo Finance - August 17th, 2020
- How can you actively boost your low libido? - Big Think - August 11th, 2020
- Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - BioSpace - July 30th, 2020
- Hormone therapy no cure-all for 'low T' in ageing men - Health24 - July 20th, 2020
- Strain engineering of the magnetic multipole moments and anomalous Hall effect in pyrochlore iridate thin films - Science Advances - July 20th, 2020
- Does Low Testosterone Cause Night Sweats? - July 7th, 2020
- Treating low testosterone levels - Harvard Health - July 7th, 2020
- Some people who experienced no coronavirus symptoms may now be immune to Covid-19 - here's what the study says - Derry Journal - July 4th, 2020
- AGING: Hormone therapy no cure-all for low T in men - Palm Beach Post - July 2nd, 2020
- COVID 19 Effect on Low T Therapy Market: an Increase in Technology Development Will Heighten Growth of Key Players: AbbVie, Endo International, Eli... - June 23rd, 2020
- Freddy McConnell Gave Birth to His Son. Then His Life Changed. - Esquire - June 18th, 2020
- Low T Therapy Market: What Will Happen to Key Players After COVID 19 Ends: AbbVie, Endo International, Eli Lilly - Cole of Duty - June 9th, 2020
- Ego might drive men to testosterone therapy, but it helps with certain conditions - The Columbus Dispatch - June 8th, 2020
- What Are T-Cells and Can They Protect You from COVID-19? - Labmate Online - June 8th, 2020
- Aytu BioScience to Report Fiscal Q3 FY 2020 Results and Business Update - Yahoo Finance - May 7th, 2020
- COVID-19: T cells offer clues to the potential power of Roche's Actemra - FierceBiotech - May 6th, 2020
- Peek on Low T Therapy Market Future, Extensive Studies and Prediction of Top Manufacturers Condition: AbbVie, Endo International, Eli Lilly - 3rd... - May 6th, 2020
- New clues on how to treat COVID-19 from T cell counts - The Nation - May 3rd, 2020
- Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment... - April 29th, 2020
- Low T Center Is Committed To Meeting The Needs Of Colorado Patients During The COVID-19 Emergency - P&T Community - April 20th, 2020
- Aytu BioScience Announces Positive Results from an Independently Conducted Clinical Study of the Company's Licensed COVID-19 IgG/IgM Point-of-Care... - April 17th, 2020
- The testosterone myth - The Week Magazine - April 12th, 2020
- Low T Therapy Market Industry Analysis, Size, Share, Growth, Trends And Forecast 2020 2024 - Monroe Scoop - March 26th, 2020
- Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company's Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care... - March 23rd, 2020
- No, not everything about mens sexual behaviour can be explained by testosterone - Scroll.in - March 23rd, 2020
- Letters to the editor - Boston Herald - March 9th, 2020
- Low Testosterone - Symptoms & Treatment | Everyday Health - March 6th, 2020
- Lost revenue from low T fares must be recouped - Boston Herald - March 1st, 2020
- Indiana Regenerative Medicine Institute Offers Innovative Approaches in Regenerative Medicine, Hormone Replacement and Pain Management - Carmel... - March 1st, 2020
- Low Testosterone Causes | Everyday Health - February 24th, 2020
- Diagnosis, treatment and how to avoid osteoporosis - The Gazette - January 30th, 2020
- The Signs a Testosterone Booster is Needed - Science Times - January 22nd, 2020
- New Guideline for Testosterone Treatment in Men With 'Low T' - Medscape - January 9th, 2020
- John R. Hampton III, MD, is recognized by Continental Who's Who - PRNewswire - November 27th, 2019
- Expert Insights on Osteoporosis From the ACR/ARP 2019 Annual Meeting - Rheumatology Advisor - November 27th, 2019
- Low T Specialist - Dallas, TX & Frisco, TX: Men's T-Clinic ... - October 5th, 2019
- Does Insurance Cover Low T Treatment - Mantality Health - October 5th, 2019
- Low Testosterone Therapy (TRT) and Treatment from Low T Center - September 27th, 2019
- Low T Center, 549 East County Line Road, Building 4 Suite D ... - March 31st, 2019
- Low T Symptoms | Low Testosterone | Signs of Low T - March 12th, 2019
- Low T Treatment in Texas & Illinois | SynergenX Health ... - February 18th, 2019
- The Lowdown on Low-T - Discover Health - Rush University ... - February 18th, 2019
- The Low T Scam? - Testosterone Centers of Texas - Low T ... - February 18th, 2019
- Low T 99 - Testosterone Therapy: Bellevue, Seattle, Tacoma ... - December 31st, 2018
- Men, Low T, and the Facts | Lifespan - October 1st, 2018
- Denver Low T Medical Clinic and Testosterone Therapy Center - August 6th, 2018
- You've Heard About "Low T" But What About "Low E"? - April 23rd, 2018
- Low T 99 - 10 Photos - Health & Medical - 1239 120th Ave NE ... - April 23rd, 2018
- Low Testosterone Treatment - Carolina Men's Clinic - April 23rd, 2018
- Low T-Helper (CD4) Cell Level - Symptoms and Diagnosis - March 2nd, 2018
- ED Clinic Nashville TN, Erectile Dysfunction Treatment, Low T - February 10th, 2018
- Low-Testosterone (Low-T) - Controversy Over ... - AARP - January 11th, 2018
- Low testosterone symptoms | Effects of low testosterone - January 11th, 2018
- About Low Testosterone | Low T Center - December 29th, 2017
- Low Testosterone Replacement Therapy | Low T ... - Men's T Clinic - November 12th, 2017
- low t | eBay - November 12th, 2017
- Low Testosterone (Low T) Treatments - onhealth.com - November 2nd, 2017
- Low-T (Low Testosterone) Quiz: Symptoms, Signs & Treatment - October 22nd, 2017
- Erectile Dysfunction/Low T Men's Health Georgia - September 4th, 2017
- 10 easy ways to transform old band T-shirts into something new - Alternative Press - August 30th, 2017
- AbbVie Hit With $150 Million Loss in Low-T Cardiac Trial - Lexology (registration) - August 19th, 2017
- Low T Center returning to sponsor Sorenson - ESPN - August 18th, 2017
- Older men with 'low T' can improve their sex lives with testosterone therapy, study says - Men's Fitness - August 18th, 2017
- Center for Men | Tulsa Men's Clinic | Tulsa Low T - August 17th, 2017
- `Make Men Great Again' Speakers Bash Trans People While Pumping Up America's Girly Men - Southern Poverty Law Center - August 10th, 2017
- Doctors Address Low Testosterone Ads - CBS St. Louis - August 9th, 2017
- Low T - Testosterone Replacement Therapy - Ehormones - August 2nd, 2017
- What does a low T cell count mean? DoctorNDTV Queries - August 2nd, 2017
- Column: Testosterone treatment reserved for men with symptoms ... - The Daily Courier - July 5th, 2017
- Testosterone treatment reserved for men with symptoms - Sarasota Herald-Tribune - July 5th, 2017