Osteoporosis is a situation during which bones change into porous (much less dense) and weaker. It impacts 10 million folks in the US: roughly eight million girls and two million males. As bone weakens, individuals are extra more likely to expertise fractures, particularly within the backbone, hip, and forearm. This causes ache, diminishes an individual’s capacity to perform, and reduces high quality of life. Something that may decrease the danger of osteoporosis and fractures has main optimistic public well being implications. That’s why a brand new drug referred to as romosozumab is getting lots of consideration.
Which drugs can assist deal with osteoporosis?
There are presently a number of drugs obtainable to deal with osteoporosis. These embrace drugs that
- block the breakdown of bone (anti-resorptive therapies). Examples embrace bisphosphonates akin to alendronate (Fosamax), which is a capsule, and zoledronate (Reclast), which is given intravenously. Different forms of anti-resorptive brokers embrace raloxifene (Evista) and denosumab (Prolia).
- improve the formation of bone (anabolic therapies). Examples embrace teriparatide (Forteo) and abaloparatide (Tymlos).
Now, for the primary time since 2010, a brand new class of treatment is accessible to deal with osteoporosis. Romosozumab (Evenity) is in a category referred to as sclerostin inhibitors and is taken into account an anabolic agent.
Sclerostin is a protein that helps regulate bone metabolism. Produced by osteocytes (bone cells), it inhibits bone formation (making new bone). Romosozumab binds sclerostin, which retains it from blocking the signaling pathway for brand spanking new bone formation. The consequence is a rise in new bone. To a lesser diploma, it additionally decreases bone resorption (breakdown of bone).
Romosozumab is accepted by the FDA to deal with osteoporosis in girls who’ve accomplished menopause and are at excessive danger for fracture. A historical past of fracture as a result of osteoporosis, a number of danger elements for fracture, no success with different therapies, or being unable to tolerate different therapies are causes to think about romosozumab.
How is romosozumab given?
The treatment is injected as soon as a month utilizing two separate prefilled syringes for a full dose. Romosozumab ought to solely be taken for one 12 months, as a result of its bone-making exercise wanes after 12 months. Ladies utilizing this remedy must also ensure they get sufficient calcium and vitamin D throughout remedy.
What does analysis inform us?
Two massive trials in The New England Journal of Medication (which had been funded by the drug producer) have checked out this new treatment. One trial enrolled over 7,000 postmenopausal girls with osteoporosis primarily based on low bone density measurements. Half obtained romosozumab and half placebo (inactive treatment) for one 12 months. Ladies utilizing romosozumab versus placebo had far fewer new vertebral fractures: 16 within the remedy group, 59 within the placebo group.
Within the second 12 months of the research, all members — together with those that had been taking a placebo — got the anti-resorptive agent denosumab. The group that obtained romosozumab adopted by denosumab had 21 vertebral fractures, in comparison with 84 within the group that obtained placebo adopted by denosumab.
One other trial enrolled greater than 4,000 postmenopausal girls with osteoporosis and a historical past of associated fractures. Half had been handled with a month-to-month injection of romosozumab for one 12 months, adopted by alendronate as soon as per week for the second 12 months. The opposite half obtained alendronate as soon as per week for each years.
On the finish of the research:
- these assigned to obtain romosozumab within the first 12 months had fewer new backbone fractures than these receiving alendronate for each years (127 vs. 243)
- hip fractures additionally occurred much less usually amongst these receiving romosozumab (41 versus 66)
- bone density was larger within the group that obtained romosozumab.
What are the attainable uncomfortable side effects?
Joint ache and headache are the most typical uncomfortable side effects of romosozumab. Very not often, some folks expertise lack of bone tissue (osteonecrosis) within the jaw and atypical thigh bone fractures. (This additionally happens very not often with bisphosphonates and denosumab.)
Moreover, the danger of coronary heart assaults, stroke, and cardiovascular demise was barely larger amongst these given romosozumab within the first 12 months than it was amongst these given alendronate for each years. When you have had a coronary heart assault or stroke, or are at excessive danger for both, ask your physician whether or not you must select a special kind of osteoporosis treatment.
The underside line
We don’t but have long-term knowledge on romosozumab. However a twin impact (growing bone formation and lowering bone resorption) makes it a welcome addition to obtainable therapies for osteoporosis — no less than for postmenopausal girls at excessive danger for fracture.
Primarily based on this analysis, a 12 months of romosozumab remedy, adopted by an anti-resorptive agent like alendronate, zoledronate, or denosumab, is a brand new and efficient choice for sure girls to forestall fractures associated to osteoporosis. Nevertheless, price could also be an element, and there could also be small however essential dangers to grasp about this method when discussing your remedy choices together with your physician. Finally, extra long-term analysis is required to assist decide security and effectiveness over time.
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