The American Medical Association (ACP) has updated drug therapy guidelines to reduce the risk of primary fractures in adults. osteoporosis Osteopenia (low bone mass) based on systematic review of evidence.
This is the first update in five years since the previous guidance was issued in 2017.
Initial treatment with bisphosphonates is strongly recommended for postmenopausal women with osteoporosis and men with osteoporosis.
But Susan M. Ott, M.D., author of an accompanying editorial, says, “The decision to start a bisphosphonate isn’t really that easy.”
She also asks about some of the guidance’s other recommendations.
she edit, together guidelines By Amir Qaseem, MD, PhD, MPH, and colleagues systematic review Published 2 January by Chelsea Ayers, MPH, and colleagues. Chronicle of internal medicine.
Ryan D. Mire, MD, MACP, President of ACP, said: brief overview of the new guidance in the video.
systematic review
The ACP has requested a review of the evidence, stating that it has uncovered new data on the effectiveness of new agents, treatment comparisons, and treatments in men for osteoporosis and low bone mass.
The review authors identified 34 randomized controlled trials (100 publications) and 36 observational studies evaluating the following pharmacological interventions:
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Antiresorptive drugs: 4 types of bisphosphonates (alendronate, ibandronic acid, risedronatezoledronate) and a RANK ligand inhibitor (denosumab).
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Anabolic drugs: analogs of human PTH-related proteins (abaloparatide), recombinant human PTH (teriparatide), and sclerostin inhibitors (romosozumab).
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estrogen Agonists: selective estrogen receptor modulators (SERMs) (bazedoxifene, raloxifene).
The authors focused on the efficacy and harms of active drugs compared to placebo or bisphosphonates.
Major changes from 2017 guidelines, some questions
“There are many subtle changes to this, [2023 guideline] A version, perhaps the major change, is the explicit hierarchy of pharmacological recommendations: bisphosphonates first. ” denosumabexplained Thomas G. Cooney, MD, senior author of the clinical guideline. Medscape Medical News on mail.
“Bisphosphonates had the most favorable balance between benefits, harms, patient values and preferences, and costs among the drugs tested in postmenopausal women with primary osteoporosis.” , said Cooney, a professor of medicine at Oregon Health and Science University in Portland. in guidelines.
“Denosumab also provided favorable net benefits over the long term, but bisphosphonates are much cheaper than other pharmacological treatments and are available in generic formulations,” the document states.
New guidelines suggest the use of denosumab as second-line medical therapy in adults with contraindications to or experiencing side effects from bisphosphonates.
Choice among bisphosphonates (alendronate, risedronate, zoledronate) is based on patient-centered discussions between physician and patient based on cost (often related to insurance), mode of delivery Address preference (oral or intravenous), and “value.” This includes the patient’s priorities, concerns and expectations regarding health care, he explained Cooney.
Another update to the new guideline is to “also clarify the more limited but specific roles of sclerostin inhibitors and recombinant PTH.”to reduce the risk of fractures women only primary osteoporosis Very high risk of fracture,” Cooney pointed out.
Additionally, the guidelines now state: “Therapies to Reduce Fracture Risk in Men” Rather than limiting tospine fractures in men,” as in the 2017 guidelines.
It also explicitly includes denosumab as a second-line treatment for men, Cooney said, but as in 2017, the strength of the evidence in men remains low.
“Finally, we clarified that in women 65 years and older with low bone mass or osteopenia, an individualized approach to treatment is taken (similar to previous guidelines), but if treatment is initiated bisphosphonates are used (new content),” he said.
The guidelines do not address estrogen use, duration of treatment, drug withdrawal, or continuous monitoring of bone density, but may be evaluated within 2-3 years.
“Treating Osteoporosis: It’s Not Easy“ – edit
Ott writes in her op-ed:
“Strong recommendations should only be given where future research is unlikely to change that,” continues Ott, a professor of medicine at the University of Washington in Seattle.
“However, in patients with severe osteoporosis, data already suggest that treatment should begin with anabolic agents, as previous treatment with bisphosphonates or denosumab interferes with the anabolic response to new agents.”
“Starting with bisphosphonates changes the bones so that they are less responsive to new drugs and patients miss out on the best possible improvement,” Ott explained by email. Medscape Medical News.
In practice, however, new guidance suggests considering the use of sclerostin inhibitors to reduce fracture risk in women with primary osteoporosis who are at very high risk of fracture. Romosozumab (moderate certainty evidence) or recombinant human parathyroid hormone (PTH) (teriparatide) (low-certainty evidence) followed by bisphosphonates (conditional recommendation).
Mr Ott said: [fracture] If the risk is high, anabolic drugs should be used for 1-2 years. If the risk is moderate, use bisphosphonates for up to five years, then stop and monitor the patient for signs that the drug is becoming less effective,” says blood and urine tests. Based on
“Need a drug to stop bone aging”
Ott explained that osteopenia is defined by any bone density measurement. “About half of women over the age of 65 have osteopenia, and by the age of 85 there are very few women left who are ‘normal’.
“We need a drug that stops bone aging. This may sound impossible, but you still have to try,” she continued.
“In the meantime, pending new findings, I would not use bisphosphonates in patients who have not yet had a fracture or who have bone density T-scores better than -2.5.” In a study Alendronate Fractures in this group could not be prevented. “
Many people worry about bisphosphonates because they have problems with their jaws and femurs. These are real, but very rare in the first 5 years of treatment, after which the risk begins to rise, and after 8 years he is over 1 in 1000. Therefore, people can get the benefits of these drugs for five years with very low risk.
“straight away [guideline] We need updated information to address the severity of bone loss and the increased risk of vertebral fractures after denosumab discontinuation,” urged Ott.
“I do not agree with the use of denosumab as second-line treatment for osteoporosis,” she said. If it is necessary and must be discontinued, treatment with bisphosphonates is recommended. Even patients and far too many doctors don’t realize how serious skipping a dose can be.
“I also think men can be treated with anabolic drugs,” Ott said. Many men suffer from osteoporosis as a result of being underweight. testosterone, which can then usually be treated with testosterone. “Osteoporosis in men is a serious problem, often ignored, and bordering on reverse discrimination.”
It’s also disappointing that the review and recommendations for estrogen, one of the most effective drugs for preventing osteoporotic fractures, isn’t covered, according to Ott.
Clinical considerations in addition to drug type
The new guidelines also recommend:
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Clinicians treating adults with osteoporosis should encourage adherence to recommended therapies and healthy lifestyle habits, including exercise, and counseling for fall assessment and prevention.
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All adults with osteopenia or osteoporosis should get enough calcium and Vitamin D Taken as part of fracture prevention.
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Clinicians should assess baseline fracture risk based on bone density, history of fractures, fracture risk factors, and response to previous osteoporosis therapy.
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Current evidence suggests that bisphosphonate therapy continued for more than 3 to 5 years reduces the risk of new vertebral fractures, but not other fractures. However, it also increases the risk of long-term harm. Therefore, clinicians should consider discontinuing bisphosphonate treatment after 5 years unless the patient has a strong indication for continued treatment.
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Decisions on bisphosphonate leave (temporary discontinuation) and its duration should be based on baseline fracture risk, drug half-life in bone, and benefits and harms.
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Women who have been treated with anabolics and who discontinue them should be offered anti-resorptive drugs to maintain their benefits and because they are at significant risk of rebound and multiple vertebral fractures.
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Adults over the age of 65 with osteoporosis may be at increased risk of falls and other adverse events from drug interactions.
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Transgender people have different risks of low bone mass.
The review and guidelines were funded by ACP. Ott reported no relevant disclosures. Relevant financial disclosures for other authors are listed along with guidelines and reviews.
An intern doctor. Published online on January 2, 2023. guidelines, review, editorial
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