Prolia, also known as denosumab, is an IgG2 monoclonal antibody with affinity. It has specificity for the human receptor activator of nuclear factor kappa-B ligand (RANKL), offering a sterile, preservative-free treatment for osteoporosis. Women who receive a shot of Prolia typically have a higher risk of fracture after going through menopause.
Men can take Prolia when they’ve been diagnosed with osteoporosis too, along with the same high risk of experience fracture. Patients who have not responded well to other therapies for their diagnosis are sometimes candidates for this therapy also.
It was first approved for use in the United States in 2010. Only specific types of patients are allowed to receive this prescription treatment.
If you’re concerned about osteoporosis, believe that you have a high risk of fracture, or you have a history of fractures already, then here are the pros and cons of Prolia to discuss with your doctor.
List of the Pros of Prolia
1. Prolia is a proven treatment for people with a high risk of fracture.
The clinical studies involving Prolia lasted for three years. During the research phase for this shot, post-menopausal women had fewer fractures when taking denosumab compared to women who did not. There were increased levels of bone density experienced by women during the research phase too.
Women who took Prolia over 36 months reduced their risk of a new spinal fracture by 68%. Those who were not taking this drug experienced a spinal fracture 7.2% of the time, compared to the 2.3% of women taking Prolia.
2. Prolia is easy to administer.
You only receive two injections of Prolia each year. Most people receive the injection in their upper arm, upper thigh, or their stomach. Healthcare providers must give you this injection, even if you are approved to self-inject other medications at home already. If you are prescribed a denosumab product, there is a good chance that you’ll be asked to take extra Vitamin D and a calcium supplement to help the biologic-based treatment work as it should.
3. Prolia may reduce breast cancer recurrence in some women.
The ABCSG group in Australia performed a research study with over 3,400 post-menopausal women who were also diagnosed with hormone-receptor-positive non-metastatic breast cancer. Each woman took an aromatase inhibitor and a 60mg dose of denosumab (or a placebo). They found that reductions of 18% for recurrence risk factors were present in the group who took Prolia. Even with women who had larger tumors, there was a clear trend toward resistance when taking these shots.
4. Prolia is well-tolerated by most men and women, despite the potential for side effects.
With most double-blind clinical studies, the doctors involved often know which patients receive the medication and which do not because of side effect complaints. When Prolia is studied, the investigators couldn’t tell who received the medication because the shots are so well tolerated. Every medication offers the possibility of a rare adverse event, and this option is no different. For those affected by osteoporosis, however, Prolia is one of the safest treatment options available right now.
5. Prolia cuts down on the cost of healthcare for individuals and society as a whole.
According to data published by the Centers for Disease Control and Prevention (CDC), over 250,000 people above the age of 65 are hospitalized each year because of a hip fracture. The lifetime cost to care for a hip fracture is above $81,000, which includes nursing facility expenses. When all the other fracture incidents are included in this data too, each shot of Prolia offers the potential to save over $160,000 in lifetime care costs for each patient.
6. Prolia is just as useful as bisphosphonates.
Injectable Prolia is found to be as effective as the current standard of osteoporosis care in the United States, which happens to be bisphosphonates. The way the treatments work, however, is very different. Bisphosphonates treat the condition by layering on the surface of the bone. The osteoclasts then consume it, reducing their activity to remain in the bone for a more extended period. Prolia reduces the messaging which increases osteoclast activities in the first place. Because of the biological change which occurs, most patients will receive the standard treatment first, then Prolia if that option doesn’t work for them.
7. Prolia doesn’t need to be a long-term approach to osteoporosis care.
This drug does not linger in the bones for an extended time like bisphosphonates do when treating osteoporosis. It is a finite medication. If you and your doctor feel like this treatment option isn’t working for you, then you can switch to something else after the six-month period of activation passes. That means you have more opportunities to pursue alternative therapies for your treatment plan if the drug doesn’t produce results.
8. Prolia encourages better medication adherence.
Some osteoporosis treatments require the taking of regular medications, sometimes on a daily basis. When you take daily or weekly meds, then it is easier to forget them, which takes you off your recommended dosage cycle. Prolia offers a reduced risk of this issue because it comes in the form of two shots. Your doctor administers the shot for you, so the only thing you need to remember is to confirm your scheduled follow-up after each appointment.
This may be the most significant advantage Prolia offers over other osteoporosis treatments. Doctors know the treatment is administered, which means there is added confidence to the results available to each patient.
9. Prolia offers fewer next-day symptoms compared to other long-term options.
Reclast is the other long-term osteoporosis treatment often considered by patients who don’t want to be taking medication regularly. It offers a once-per-year treatment requiring IV administration. Up to 60% of the patients who take Reclast experience an acute-phase reaction the day after their first dose which is similar to flu-like symptoms. This may prevent some people from returning for another dose. Prolia rarely causes an issue such as this once administered.
10. Prolia is covered under Medicare Part B in the United States.
Although cost may be an issue for some patients when considering Prolia, Medicare pays for it like they would an office procedure or an x-ray. Most commercial insurance companies and payers offer coverage for the right patients too, usually those who already tried the cheaper bisphosphonates and failed. That means the actual costs of each shot are minimal for the average person, with some patients potentially receiving this drug without any cost at all.
11. Prolia bypasses the digestive system.
Bisphosphonates taken by mouth are not readily absorbed by the body. Many people experience uncomfortable gastrointestinal side effects when taking them, including stomach pain, nausea, heartburn, and diarrhea. Some people will develop peptic ulcers when taking this series of osteoporosis medication. The pills are large enough that they’re not easy to take either. That’s why the Archives of Internal Medicine notes that 45% of women who are prescribed osteoporosis medication stop taking the drugs within the first year.
Prolia changes this dynamic. Because you’re taking a shot, you get to bypass the digestive system altogether. Many of the uncomfortable side effects associated with osteoporosis medication are reduced or eliminated by this biologic. That offers the potential for better compliance, improved care, and fewer fractures over time.
12. Prolia offers a competitive cost profile.
If you must pay for Prolia out-of-pocket because it isn’t covered by your insurance, then the price is only about $600 more than bisphosphonates and about $400 more than Reclast per year. Although some households could struggle with these costs, the competitive pricing for this drug with all of its benefits makes for a tempting treatment opportunity.
List of the Cons of Prolia
1. Prolia may cause future health issues in some patients.
This drug works by slowing down the bone-breakdown process in the body. That counteracts the shift in estrogen levels that post-menopausal women experience, reducing the issues of bone loss that occur with this diagnosis.
The drug also slows the bone-remodeling process at the same time. Doctors are asked to look for atypical fractures, delayed healing, and osteonecrosis of the jaw when prescribing Prolia to their patients.
2. Prolia may impact the immune system in negative ways.
This drug targets human RNAKL, which plays several different roles for the immune system. Women taking Prolia had a higher risk of experiencing a severe infection after receiving the shot, leading to higher hospitalization rates. This issue included heart infections. There were also issues with specific skin reactions related to eczema, dermatitis, and rashes when taking denosumab.
3. Prolia comes with side effects to consider before taking it.
The most common side effects of this drug involve pain located in the back, feet, hands, muscles, or bones. Some women (and men) experience higher cholesterol levels when taking Prolia. There is an increased risk of having a bladder infection when on this medication as well. Patients who take denosumab also tend to have lower calcium levels, so anyone found to be deficient in this mineral should not take the drug unless specifically directed by their doctor.
Some people who have taken Prolia experienced unusual thigh bone fractures after receiving their shots. New or unusual pain in the thigh, hip, or groin may indicate this occurred. There are additional side effects which may also occur.
4. Prolia doesn’t offer much information about results.
With less than 10 years of approval in the United States, the number of patients currently taking this prescription medication is few. According to WebMD, about 4,500 women take the drug, along with an unknown number of men. There are risk evaluation and mitigation strategies offered by the manufacturer, but it only offers a surveillance program to monitor those who take the shots. There isn’t enough long-term data about Prolia to understand what the consequences may be for some individuals if they choose this treatment option.
5. Prolia is an expensive treatment option for some people.
Although Prolia is somewhat cheaper than other biologic therapies which are available today, the cost is still higher than some households may want to pay. The wholesale price of each shot is $825, which means the treatment cost is over $1,650 each year. Adding in the doctor visits, administration costs, and follow-up appoints (and the markup for billing), the cost may exceed $5,000 annually for some patients. Some health insurance plans may cover this prescription, so confirm that information before discussing the other pros and cons of Prolia with your doctor.
6. Prolia must be taken continuously to maintain its benefits.
You should not stop taking Prolia once your treatment series begins. If you stop receiving the biannual injections, then your risk for breaking or fracturing bones increases. That includes a higher risk of breaking the bones in your spine. Always take your Vitamin D and calcium supplements when taking a denosumab injection too to prevent unintended outcomes.
7. Prolia research studies are supported by the manufacturer.
The studies which show positive clinical results for Prolia are directly supported by Amgen, who is the current manufacturer of the drug. For the ABSCG study, the doctor involved with the work says he did not receive grant support from the manufacturer, but he does receive consulting fees and grants from other pharmaceutical companies. Because the clinical research stage must offer success before approval for distribution occurs, some may question the authenticity of the data generated from these studies.
8. Prolia requires more administrative work for doctors.
Prolia is a drug which receives compensation after administration. That means healthcare providers must purchase it first, then apply for reimbursement after giving it to a patient. That increases the paperwork involved with this treatment option, which could also push its price upward for some people because of the extra administrative work. Because the initial costs must be fronted, some doctors might think twice about offering this drug as a treatment option compared to those who don’t have the same requirements.
9. Prolia is not intended for prevention.
This drug works to reduce the impacts of osteoporosis after diagnosis. It is not designed to provide a layer of proactive protection against the health issue in post-menopausal women. You must continue with an adequate calcium intake to reduce the risks of osteoporosis in the first place. Avoid strict weight-loss diets, maintain Vitamin D levels, and avoid heavy drinking or smoking. Exercise is good for bone health as well, while balance training may help to prevent some falls which could lead to a fracture.
These Prolia pros and cons offer possible hope for men and women who struggle with osteoporosis. It may provide help when other treatment options have failed already. Make sure that you tell your doctor about all the medical conditions you have before starting these shots, including if you’ve had thyroid surgery, have kidney problems, or plan to have dental surgery in the near future. You should also not take Prolia if you’re already taking XGEVA since the medication is the same.