Treatment FAQ

after 4 to 5 years of prolia usage what should the treatment be

by Enos Schoen II Published 2 years ago Updated 1 year ago

You should speak with your doctor about a “drug holiday” after 4-5 years of treatment with a bisphosphonate (drug holidays are not recommended with Prolia). For woman at low risk of having an osteoporotic fracture, harm is likely to outweigh benefit.

Full Answer

Is it dangerous to stop taking Prolia?

 · There is no recommended time of treatment for Prolia Injections, clinical studies have often been three years and at least one study went for 8 years. The longer you take Prolia Injection the bigger the improvement in fracture risk when compared to placebo. Stopping Prolia injections can cause a rebound increase in bone turnover which increases risk of multiple …

Is Fosamax better than Prolia?

 · Prolia injection side effects can happen. However, both Dr. Adachi and Amgen state that serious side effects are rare. Dr. Adachi’s experience is that most side effects last a short time (less than 3 months), and many Prolia side effects can be treated and reversed. Prolia and Your Doctor.

How long will the side effects of Prolia last?

 · Ongoing Prolia Injections after 5 years. LowellGeorge (Inactive) Jan 31, 2016 • 10:30 AM (edited Jan 31) I would really like to hear from people who have had 5 years or more of Prolia. I am about to receive my 10th injection and my Endocrinologist says that I can now take a "Prolia holiday" - meaning no injections for a while.

Does Prolia weaken your immune system?

 · Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D …

Objective of This Article on Prolia Shot

The objective of this article is to provide you with the information you need to have an intelligent and informed discussion with your physician re...

Sudden Stop of Prolia Shot

In the video above I discuss a recent study out of Switzerland that indicates that a sudden stop in the usage of Prolia (often because your Physici...

Prolia For Osteoporosis Treatment

I asked Dr. Jonathan Adachi — one of Canada’s leading osteoporosis experts — about Prolia for osteoporosis treatment and how he decides who should...

How Long Does Prolia Stay in Your System?

Prolia is unlike bisphosphonates that stay in bone for years. It will stay in your system for around six (6) months and most of it is gone by the e...

Prolia Injection Side Effects

Prolia injection side effects are rare and, according to Dr. Adachi from Osteoporosis Canada, far fewer than what we see with bisphosphonates such...

How Long Do Prolia Side Effects Last?

According to Dr. Rick Adachi from Osteoporosis Canada, in the rare cases when they occur, Prolia side effects last up to 3 months. They do not pers...

Potential Risks of Discontinuing Prolia Injections

The potential risks of discontinuing Prolia injections treatment include an increased risk of broken bones including compression fractures. Two rec...

How Long Can You Take Prolia

How long can you take Prolia? There is evidence that Prolia medication for osteoporosis may be continued for up to ten years with ongoing improveme...

Difference Between Bisphosphonate and Prolia

Bisphosphonate medication for osteoporosis (Actonel™, Fosomax™, etc) differ from Prolia (also know as Denosumab) in how they affect the activity of...

The Switch from Bisphosphonate to Prolia

The switch from bisphosphanate medication to Prolia is recommended by osteoporosis specialists when patients experience side effects from the bisph...

How long can you take Prolia?

A key question patients struggle with is how long can you take Prolia? If you start Prolia injections, you should plan on being on the treatment for life. Discontinuing Prolia usage (without going onto another pharmaceutical to maintain the gains you made) could have serious, irreversible side effects. These side effects include multiple vertebral compression fractures and a lowering of your bone mineral density.

How does Prolia affect bone?

Prolia influences the bone remodelling process by binding to these cells that become osteoclasts. This binding effect leads to the death of the osteoclasts and thus stops bone breakdown.

What are the effects of prolia and bisphosphonates on osteoclasts?

Effect on Osteoclast Cells. First, Prolia and bisphosphonates differ in how they affect osteoclast cells. Osteoclast cells are the cleaners of old bone. The newly formed osteoclast cells join mature osteoclasts to perform an important role: the breakdown of the old bone.

What happens when bisphosphonates bind to osteoclasts?

When they bind to these cells, this leads to the death of the osteoclasts cells and thus stops bone breakdown. Bisphosphonates, on the other hand, reduce osteoclast activity. This, in turn, leads to a slowdown in the turnover of bone and removal of old bone. Differences Between Bisphosphonates and Prolia.

What is Prolia monoclonal antibody?

Kent McLeod, pharmacist and owner of NutriChem Pharmacy, defines Prolia as an immunoglobulin monoclonal antibody — a glycoprotein that interferes with the protein RANK ligand (RANKL) and prevents the formation, maturation and survival rates of osteoclasts. RANKL is the molecule blocked by denosumab.

Can Prolia cause compression fracture?

In the video, above, I discuss a recent study out of Switzerland that indicates that a sudden stop in the usage of Prolia (often because your Physician sees that the medication has been very effective) could lead to incidence of compression fracture. This development could have an impact on how long can you take Prolia.

Can prolia be treated?

Prolia need not be the treatment of choice if your diagnosis places you in a low or moderate fracture risk category. The right combination of exercise and good nutrition can help you to stay (or move you into) the low risk fracture risk category.

What happens after discontinuation of Prolia?

Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Cessation of Prolia treatment results in markers of bone resorption increasing above pretreatment values then returning to pretreatment values 24 months after the last dose of Prolia. In addition, bone mineral density returns to pretreatment values within 18 months after the last injection. [see Pharmacodynamics ( 12.2) and Clinical Studies ( 14.1)].

How long does it take for Prolia to cause pain?

The time to onset of symptoms varied from one day to several months after starting Prolia. Consider discontinuing use if severe symptoms develop [see Patient Counseling Information ( 17.9 )].

When does the nadir occur after Prolia?

The nadir in serum calcium level occurs at approximately day 10 after Prolia dosing in subjects with normal renal function. In clinical studies, subjects with impaired renal function were more likely to have greater reductions in serum calcium levels compared to subjects with normal renal function.

Can adverse reaction rates be directly compared to rates in clinical studies of another drug?

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Does Prolia cause back pain?

The most common adverse reactions reported with Prolia in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. The most common adverse reactions reported with Prolia in men with osteoporosis are back pain, arthralgia, and nasopharyngitis.

Does Prolia cause hypocalcemia?

Hypocalcemia may be exacerbated by the use of Prolia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia. In patients predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, severe renal impairment [creatinine clearance < 30 mL/min] or receiving dialysis), clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended within 14 days of Prolia injection. In some postmarketing cases, hypocalcemia persisted for weeks or months and required frequent monitoring and intravenous and/or oral calcium replacement, with or without vitamin D.

Is Prolia a clinically significant hypersensitivity?

Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )].

How often is Prolia given?

Prolia is administered by injection under the skin of the upper thigh, abdomen, or upper arm, once every six months. The dosage of Prolia does not need to be reduced in people with kidney disease. 3. Downsides.

How long does Prolia stay in the refrigerator?

Prolia must be stored in the refrigerator until needed for use. The risk of fracture, including multiple vertebral fractures, increases when Prolia is discontinued, and new vertebral fractures have been reported in as little as 7 months following discontinuation. The risk decreases to pretreatment values within 24 months.

How to inject Prolia under skin?

Once at room temperature, remove the grey needle cap and insert the needle under the skin of the upper thigh, abdomen, or upper arm. Push the plunger to inject the dose of Prolia under the skin. When finished, click the green safety guard into place (there is no need to replace the grey needle cap).

How long does it take for Prolia to warm up?

Immediately before administration, take Prolia out of the refrigerator and leave in its original container to warm up to room temperature for around 15 to 30 minutes.

Can you self administer Prolia?

Prolia is only available as an injection; however, people can be taught how to self-administer Prolia. The grey needle cap that fits onto the end of a pre-filled syringe of Prolia should not be handled by people with latex allergies because it may cause a reaction.

What are the symptoms of Prolia?

Severe allergic reactions have been reported with Prolia and symptoms have included low blood pressure, shortness of breath, facial and throat tightness, and rash.

How much vitamin D is needed for prolia?

People undergoing Prolia therapy need to receive calcium 1000mg daily and at least 400 IU vitamin D daily. Prolia has been associated with osteonecrosis of the jaw. The risk of osteonecrosis of the jaw is greater in those who have received chemotherapy, radiation, or steroids.

How often is Prolia injected?

Prolia, with the generic name Denosumab, is a type of monoclonal antibody, which stops the natural breakdown of bones. Prolia is injected two times per year. It should only be used if other treatment methods have failed or by post-menopausal women who have severe osteoporosis. The National Women’s Health Network suggests women try other ...

How to prevent osteoporosis without medication?

Answer. There are many ways to prevent and treat osteoporosis from worsening without taking medications. One way is through your diet. It is important to get adequate amounts of calcium and vitamin D because they help build and preserve your bone strength.

What is the best treatment for osteoporosis?

Long-term use of bisphosphonates increases the risk of fractures so they should not be used beyond 3-5 years. Prolia, with the generic name Denosumab, is a type of monoclonal antibody, which stops the natural breakdown of bones. Prolia is injected two times per year. It should only be used if other treatment methods have failed or by post-menopausal women who have severe osteoporosis. The National Women’s Health Network suggests women try other FDA-approved osteoporosis medications prior to trying Prolia . This drug has a long list of side effects and it’s also important to note that long-term risks are unknown. The FDA Medication Guide lists the potential health problems, which include serious infections, thighbone fractures, and jaw bone problems. It is unclear if the benefits outweigh the risks.

How to prevent osteoporosis?

Exercise is another way to help prevent osteoporosis. Per the National Osteoporosis Foundation, weight-bearing and muscle-strengthening exercises are both important for building and maintaining bone density. Examples of weight-bearing exercises include hiking, jogging, and stair climbing.

What is the best drug for rebound fractures?

Alendronate (Fosomax) is the drug of choice for hopefully maintaining bone density and preventing rebound fractures after stopping Prolia according to my Stanford doctor. Alendronate can be taken as a 5 mg daily dose (or 35 mg weekly). I asked her about Actonel and she said not proven.

Can you take prednisolone with osteoporosis?

Prednisolone and omeprazole should not be taken by people with osteoporosis as they wreak havoc with bone density, the latter by decreasing stomach acid and hence absorption of calcium and other minerals. Re calcium and vitamin D: I omitted them in error from my list of supplements, so do take them every day.

Can you stop Prolia?

Yes, that is the scary part - they are fully aware that there are health-compromising issues once people want/need to stop Prolia, but just carry on merrily prescribing it (and probably not informing their patients of the implications of discontinuing it). I did ask the endocrinologist what happens once all the people now on Prolia get to the 10-year safe limit. She told me that it'll probably be extended to 20 years as further testing will have been done by that stage. Well, that's all hypothetical, to my mind. What if people HAVE to stop taking it because it hasn't proven to be safe after 10 years of use? There will be masses of people having rebound vertebral fractures - and their bones will be in far worse condition after 10 years of turnover/resorption being slowed than mine are after 2 years. I think it's criminal, but there's a lot of money involved, as usual...

Does reclast work?

Yes, I read that reclast works best when bone resorption has already begun but difficult to time. I won't be able to have the infusion anyway (unless something dire happens with my bone resorption on the Actonel 5mg and I get desperate).

Can you take bisphosphonate for rebound fractures?

So an oral bisphosphonate may turn out to be the treatment of choice. Hope this helps.

Do health forums have a lifesaver?

Yes, these health/public forums have been a lifesaver for me too! What did we do before the internet!

How long does Prolia stay in your system?

Prolia stays in your body for over 4 months so some of these side effects can last a long time. Another side effect of Prolia is that it can cause an increase in bone breaks when you stop using it.

What are the side effects of Prolia?

Official Answer. The most common side effects of Prolia are fatigue (45%), body weakness and lack of energy (45%), back pain (35%), low phosphate levels (32%), nausea (31%) and diarrhea (20%). It is difficult to say what will happen with these side effects.

How long does Prolia last?

It works by turning off the natural process of breaking down and reabsorbing bones. It is administered through a shot twice per year for up to 10 years.

Can you stop Prolia without a plan?

In clinical trials, results also suggest that people who stop taking Prolia and did not start another treatment experienced more vertebral fractures in the 10 months after treatment than people who had been taking a placebo. Researchers and physicians recommend that you do not stop taking Prolia without making a plan for further bone treatment.

Does denosumab cause bone loss?

Recent studies have shown that people who stop taking denosumab experience bone loss within the first year if they do not start taking a new osteoporosis treatment. Clinical trials have demonstrated a rapid decrease in bone mineral density (BMD) and an increase in bone turnover markers (BTMs).

Does denosumab help with hip fractures?

Denosumab has proven effective at building bone density and reducing spine and hip fractures. However, it carries a risk of serious side effects. People with weakened immune systems are advised not to use to denosumab because it can lead to serious infections that require hospitalization (such as heart infections).

Can you take denosumab after 10 months?

In clinical trials, results also suggest that people who stop taking denosumab and did not start another treatment experienced more vertebral fractures (fractures in your spine) in the 10 months after treatment than people who had been taking a placebo. For these reasons, pausing your treatment or taking a “drug holiday” is not recommended ...

How long should you wait to re-evaluate denosumab?

Clinicians and patients should be aware of this potential risk. Based on available data, a re-evaluation should be performed after 5years of denosumab treatment. Patients considered at high fracture risk should either continue denosumab therapy for up to 10years or be switched to an alternative treatment.

Where is the 9Mellanby Centre for Bone Research?

9Mellanby Centre for Bone Research, University of Sheffield, UK.

Does denosumab affect bone turnover?

As opposed to bisphosphonates, denosum ab does not incorporate into bone matrix and bone turnover is not suppressed after its cessation. Recent reports imply that denosumab discontinuation may lead to an increased risk of multiple vertebral fractures.

How It Works

Upsides

Downsides

  • If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include: 1. Back pain, constipation, muscle pain, pain in the hands or feet, high cholesterol levels, nasal congestion, and bladder infections (in women) are the most common side effects reported with Prolia. 2. Prolia may exa…
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Bottom Line

  • Prolia is an injection that can be self-administered once every six months for the treatment of osteoporosis. It has been associated with an increased risk of fractures on discontinuation.
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Tips

  1. If you have been shown how to self-inject Prolia, administer yourself a dose once every six months, otherwise see your healthcare provider for a dose every six months. If you forget a dose, schedul...
  2. Immediately before administration, take Prolia out of the refrigerator and leave in its original container to warm up to room temperature for around 15 to 30 minutes. Do not warm in any …
  1. If you have been shown how to self-inject Prolia, administer yourself a dose once every six months, otherwise see your healthcare provider for a dose every six months. If you forget a dose, schedul...
  2. Immediately before administration, take Prolia out of the refrigerator and leave in its original container to warm up to room temperature for around 15 to 30 minutes. Do not warm in any other way....
  3. Keep Prolia in the refrigerator. Once taken out of the refrigerator, use within 14 days. Do not shake Prolia vigorously.
  4. Prolia usually needs to be taken alongside calcium and vitamin D supplements. Make sure you take your supplements as directed and talk to your doctor or pharmacist if you are unsure ab…

Response and Effectiveness

  1. Maximal Prolia concentrations are reached within 10 days of an injection, and levels of Prolia declined over four to five months.
  2. Prolia reduced the risk of vertebral fractures by 4.8%, hip fractures by 0.3%, and nonvertebral fractures by 1.5%.
  3. Bone mineral density was increased by 8.8% in the spine, 6.4% in the hip, and 5.2% in the nec…
  1. Maximal Prolia concentrations are reached within 10 days of an injection, and levels of Prolia declined over four to five months.
  2. Prolia reduced the risk of vertebral fractures by 4.8%, hip fractures by 0.3%, and nonvertebral fractures by 1.5%.
  3. Bone mineral density was increased by 8.8% in the spine, 6.4% in the hip, and 5.2% in the neck after three years of treatment with Prolia.

Interactions

  • Medicines that interact with Prolia may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Prolia. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed. Com…
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Further Information

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Prolia only for the indication prescribed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Copyright 1996-2022 Drugs.com. Revision date: November 4, 2021. Medical Dis…
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