Osteoporosis is a situation wherein bones change into porous (much less dense) and weaker. It impacts 10 million folks in the US: roughly eight million ladies and two million males. As bone weakens, individuals are extra prone to expertise fractures, particularly within the backbone, hip, and forearm. This causes ache, diminishes an individual’s potential to perform, and reduces high quality of life. Something that may decrease the chance of osteoporosis and fractures has main constructive public well being implications. That’s why a brand new drug referred to as romosozumab is getting plenty of consideration.
Which medicines might help deal with osteoporosis?
There are at present a number of medicines obtainable to deal with osteoporosis. These embody medicines that
- block the breakdown of bone (anti-resorptive therapies). Examples embody bisphosphonates reminiscent of alendronate (Fosamax), which is a tablet, and zoledronate (Reclast), which is given intravenously. Different kinds of anti-resorptive brokers embody raloxifene (Evista) and denosumab (Prolia).
- improve the formation of bone (anabolic therapies). Examples embody teriparatide (Forteo) and abaloparatide (Tymlos).
Now, for the primary time since 2010, a brand new class of remedy is out there 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 new bone formation. The end result is a rise in new bone. To a lesser diploma, it additionally decreases bone resorption (breakdown of bone).
Romosozumab is authorized by the FDA to deal with osteoporosis in ladies 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 remedy is injected as soon as a month utilizing two separate prefilled syringes for a full dose. Romosozumab ought to solely be taken for one yr, 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 giant trials in The New England Journal of Medication (which had been funded by the drug producer) have checked out this new remedy. One trial enrolled over 7,000 postmenopausal ladies with osteoporosis primarily based on low bone density measurements. Half acquired romosozumab and half placebo (inactive remedy) for one yr. Ladies utilizing romosozumab versus placebo had far fewer new vertebral fractures: 16 within the remedy group, 59 within the placebo group.
Within the second yr of the research, all contributors — together with those that had been taking a placebo — got the anti-resorptive agent denosumab. The group that acquired romosozumab adopted by denosumab had 21 vertebral fractures, in comparison with 84 within the group that acquired placebo adopted by denosumab.
One other trial enrolled greater than 4,000 postmenopausal ladies with osteoporosis and a historical past of associated fractures. Half had been handled with a month-to-month injection of romosozumab for one yr, adopted by alendronate as soon as per week for the second yr. The opposite half acquired alendronate as soon as per week for each years.
On the finish of the research:
- these assigned to obtain romosozumab within the first yr 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 increased within the group that acquired romosozumab.
What are the doable unintended effects?
Joint ache and headache are the most typical unintended 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 chance of coronary heart assaults, stroke, and cardiovascular dying was barely increased amongst these given romosozumab within the first yr than it was amongst these given alendronate for each years. In case you have had a coronary heart assault or stroke, or are at excessive danger for both, ask your physician whether or not it’s best to select a distinct kind of osteoporosis remedy.
The underside line
We don’t but have long-term knowledge on romosozumab. However a twin impact (growing bone formation and reducing bone resorption) makes it a welcome addition to obtainable remedies for osteoporosis — not less than for postmenopausal ladies at excessive danger for fracture.
Primarily based on this analysis, a yr of romosozumab remedy, adopted by an anti-resorptive agent like alendronate, zoledronate, or denosumab, is a brand new and efficient choice for sure ladies to stop fractures associated to osteoporosis. Nevertheless, price could also be an element, and there could also be small however essential dangers to know about this method when discussing your remedy choices along with your physician. In the end, extra long-term analysis is required to assist decide security and effectiveness over time.