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WARNING - Read This Before Taking Prolia
Prolia was approved in 2010 for the treatment of osteoporosis and for preventing new bone fractures especially in postmenopausal women. This new drug modifies the regulatory control of the immune system over bone remodeling. Its cutting-edge design is matched by the ease of its twice-a-year administration. But Prolia is far from the wonder drug it is being promoted as. By modifying the immune system, it impairs general immune response. And curiously, Prolia can kill off the bones of the jaw and cause hip bone fractures. Read on to find out why Prolia is definitely not what your bones need.
Prolia is a new prescription osteoporosis drug from Amgen. It is specially formulated as a twice-a-year injection to treat osteoporosis especially in postmenopausal women.
Prolia is usually recommended for osteoporosis patients with high risk of fractures particularly those at risk of developing multiple fractures.
It is also usually given as a last-line osteoporosis treatment when other osteoporosis treatments have failed. Finally, because Prolia is only given as biannual injections, it is preferred by those who prefer not to take drugs frequently and also recommended for patients who cannot tolerate other osteoporosis drugs.
The FDA (Food and Drug Administration) approved Prolia in 2010. Another drug (Xgeva) that shares the same active ingredient was also approved for treating bone cancer later that year.
The active ingredient in Prolia is denosumab. Denosumab is a human monoclonal antibody.
Prolia was the subject of a series of drug trials sponsored by Amgen including a high-profile short study undertaken by the National Aeronautics and Space Administration (NASA).
The NASA study tested the efficacy of denosumab on 24 female mice for 12 days in the microgravity environment of the International Space Station. The study concluded that Prolia prevented microgravity-induced bone loss and maintained bone mineralization.
Another landmark study was published in the New England Journal of Medicine in 2009.
In addition, there is the 3-year FREEDOM study that involved almost 8,000 postmenopausal women. It concluded that denosumab reduced the risk of osteoporosis by 35%.
Studies that compared Prolia to bisphosphonates (such as Fosamax) revealed that Prolia was slightly better than this popular class of osteoporosis and shared most of their side effects.
Prolia may be administered by a health professional or the osteoporosis patients. It is supplied as a subcutaneous injection containing 60 mg denosumab. Therefore, one Prolia injection is administered every 6 months.
The major sites of injection are under the skins of the upper arm, upper thigh and abdomen.
Denosumab is a human monoclonal antibody developed by the biotech company, Amgen. Besides its use in the treatment of osteoporosis, denosumab has also been approved or investigated for use in the treatment of rheumatoid arthritis and different forms of bone cancer.
Basically, denosumab is a RANKL inhibitor. RANKL (Receptor Activator of Nuclear Factor-kappa B Ligand) is a protein used to signal bone removal.
RANKL is naturally produced in the body and is an important part of the aspect of bone remodeling that involves bone resorption. Essentially, RANKL contributes to the removal of old bones, so new ones can form in their place.
Therefore, RANKL is linked with osteoclasts, the cells that break down the bones.
Bone remodeling or bone turnover is a two-sided process. On one side, there are osteoclasts that promote bone resorption. On the other side, there are osteoblasts and they promote the formation of new bone.
When osteoclasts predominate, bone mineral density falls. The resulting bone loss increases the risk of osteoporotic bone fractures.
RANKL is actually a surface protein found on osteoblasts. It needs to bind to RANK receptors which are found on immature osteoclast cells. Once bound to RANK receptors, RANKL encourages the maturation of osteoclasts and, by extension, increases bone resorption.
To prevent RANKL from nursing too many osteoclasts to maturation, the body produces a natural RANKL inhibitor known as osteoprotegerin.
Osteoprotegerin is a cytokine (immune system signaling protein) that prevents RANKL from overwhelming the immune system regulation of bone remodeling.
However, studies have shown that people with osteoporosis have lower levels of osteoprotegerin. In addition, the sensitivity of RANKL to this cytokine is much reduced in osteoporosis.
Therefore, denosumab serves as a replacement for osteoprotegerin by inhibiting RANKL.
Ideally, denosumab should prevent further bone loss and slow down the progression of osteoporosis. The drug does nothing for increase bone mineral density. Instead, users are encouraged to take calcium and vitamin D supplements to build new bones to replace the ones already lost.
Unfortunately, denosumab does not work quite as well as the naturally produced osteoprotegerin.
There is evidence to suggest that denosumab not only inhibits bone breakdown but also interferes with the entire process of bone remodeling. This means that it prevents the body from forming new bones and may make bones even more fragile.
In addition, the inhibition of RANKL produces some unwanted and serious side effects. Because RANKL is also used to regulate other aspects of the immune system besides bone remodeling, denosumab can impair immune response.
Given the importance of the immune system, denosumab can cause severe damage in different parts of the body.
Because there are only a few independent studies investigating the efficacy of denosumab, some experts believe that it may not be better than other osteoporosis drugs like bisphosphonates and that its only strength may be the ease of twice-yearly administrations.
Even worse, there are no studies to prove that denosumab (Prolia) is safe for long-term treatment.
The lack of long-term safety studies for Prolia makes it highly dangerous. Reading the product’s safety information on the manufacturer’s website is particularly depressing. Amgen lists a number of horrifying adverse effects of Prolia.
One can only wonder what other side effects are there if the manufacturer admits to such profound damages.
The severity of the identified side effects of this drug makes it even worse than bisphosphonates. And only time will tell what new side effects will emerge in a decade when independent safety studies are published.
Most of the side effects of Prolia are caused by its negative influence on bone remodeling and its interference with the roles of RANKL in the immune system.
RANKL, for example, is required by T helper cells. By inhibiting such immune cells, Prolia increases the chances of infections, hypersensitivity reactions and autoimmune diseases.
Even the FDA raised concerns about the effect of Prolia on important immune cells and cytokines. But then, the regulatory body approved the drug a year later.
While the disruption of the immune system is terrible, the effect of Prolia on bone remodeling is simply unforgivable. Even Amgen admits on the product page that Prolia can cause thigh bone fractures and osteonecrosis of the jaw bone.
So, what good is an osteoporosis drug that also increases the risk of osteoporotic bone fractures?
Because Prolia is far from well-studied, Amgen cannot even explain why it causes thigh bone fractures as well as pain in the thigh, groin and hip area.
However, a closer look at the effect of denosumab on bone remodeling reveals why Prolia can increase the risk of bone fractures.
By inhibiting osteoclasts, this drug interferes with normal bone homeostasis. By blocking the breakdown of old bones, Prolia inhibits bone turnover and promotes the fragility of bones. In addition, it disrupts the formation of new bone.
Without calcium, phosphate and the dozen other minerals found in the bone to recapture from broken down bones, there are no starting materials for osteoblasts to form new bones.
The situation is further worsened by the observation that Prolia lowers blood calcium level. This means that the body cannot recycle the calcium in old bones and also cannot replenish its store of the mineral.
Therefore, Prolia causes bone stasis. It does not allow old bones to be recycled and yet blocks the formation of the new ones. The result is a new kind of bone model in which the mineral density is preserved and yet is prone to fracturing.
The situation gets a lot worse in the bones of the jaw. One of the major side effects of bisphosphonates is osteonecrosis of the jaw. And this side effect is also shared by Prolia.
Jaw bone osteonecrosis is a rather peculiar condition that results after minor trauma to the jaw bone. A routine tooth extraction procedure can set it off and it is characterized by infections in the muscles surrounding the bones of the jaw.
In addition, blood supply is cut off from the area. All of these results in the death of the jaw bone.
Besides its side effects, Prolia is especially harmful to some people especially those with certain medical conditions.
First, it should be noted that Prolia is absolutely not recommended for pregnant women because it can cause birth defects.
Curiously, Prolia must also be avoided by men who are likely to impregnate their sexual partners. Evidently, Prolia affects the sperm enough to pose teratogenic risks even in fathers.
Breastfeeding women should also avoid Prolia because there is a chance (unproven) that the drug may pass on to their suckling infants and cause permanent harm to an immature immune system.
Researchers have also demonstrated that Prolia reduces the production of breast milk.
The second important contraindication with Prolia involves blood calcium level. Because Prolia can lower blood calcium level and cause hypocalcemia, users are warned to ensure that their calcium levels are sufficiently high before starting Prolia treatment.
Furthermore, users must take calcium and vitamin D supplements while taking Prolia.
Therefore, Prolia should be avoided by those at risk of hypocalcemia. Such persons include those
Lastly, those planning to have dental surgery or even routine teeth extraction should avoid Prolia.
Information on drug interactions with Prolia is lacking because there are no clinical studies that have investigated the long-term safety of the drug.
However, potential drug interactions may be inferred from the actions of Prolia.
First, Xgeva should not be combined with Prolia because they both contain denosumab.
Other drugs that may interact with Prolia include those that suppress the immune system. Combining these drugs with Prolia may significantly weaken the immune system.
Immunosuppressants to avoid when placed on Prolia include
With such harmful side effects and contraindications, Prolia is not the twice-a-year miracle osteoporosis drug it is being promoted as.
Because Amgen has partnered with GSK to market the drug, Prolia prescription will only get more common. Already, sales projections show that Prolia will grow into a multibillion dollar hit for both companies by 2015.
As sales grow, reports of side effects will also become more common and it will take the FDA too long to respond.
If you rather not be a guinea pig to Big Pharma’s new wonder drug, then you should consider natural alternatives than can help your osteoporosis.
Calcium supplementation is still good enough to help you raise your bone mineral density. But it is not the only ingredient to look out for in osteoporosis supplements. In fact, you should avoid high doses of calcium.
Along with calcium, get more magnesium, zinc, manganese, copper, phosphorus and boron.
These are the minerals that make up the bone, fix calcium to the bone matrix and give the bone its tensile strength.
In addition, vitamins D (D3) and K (K2) are absolutely essential to bone health. These vitamins improve the absorption and regulate the blood and bone levels of calcium and phosphorus. They also influence bone remodeling by balancing bone resorption with bone formation.
Furthermore, you should eat more foods that improve your bone health. While milk is tempting as a source of calcium, opt for green leafy vegetables. They are better dietary sources of calcium and they also contain vitamins D and K.
Lastly, improve your bones by making lifestyle changes such as quitting smoking and avoiding cola drinks.
Take up weight bearing and strength training exercises. These workouts put your bones to work and ensure that they are strong enough to resist bone fractures.
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