stopping bisphosphonates after 5 years

If fracture risk is high after three to five years, continue bisphosphonate treatment for up to 10 years or change therapy to a nonbisphosphonate. It is recommended that individuals take a drug holiday from a bisphosphonate after 5 to 7 years. These bone-building drugs can be taken for only one or two years and the benefits begin disappearing quickly after you stop. The benefits of taking alendronic acid generally outweigh the risks. Bisphosphonates persist in the bones for years, so 3 to 5 years of therapy is enough for many patients. After having three fractures, one serious because I ended with permanent plate and 9 screws in my ankle I decided for more calcium. (Review of the approach and To learn more about bisphosphonates, please refer to my Bisphosphonates Osteoporosis Guidelines blog post. If the bones are … As discussed in section 2, the ASBMR long-term has proposed that the risk could be reduced by taking a “holiday” from oral bisphosphonates after 5 years and from IV bisphosphonates after 3 years in patients who are at low-moderate fracture risk. Experts continue to suggest STOPPING bisphosphonates (alendronate, etc) after 3 to 5 years in patients at low fracture risk. Many female patients treated with a bisphosphonate continuously for five years or more will have ongoing benefit for a further five years if the bisphosphonate is stopped (the risk in terms of timing of use and type of bisphosphonate, and in men, remains unclear). In women with postmenopausal osteoporosis, the overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia® group. 1, 2 In a case–control study, the incidence rate was quite low (32 cases per million person-years). These benefits, however, are proven only for the first 5 … holiday”. The suggestion of stopping therapy or a drug ‘holiday’ after 5 years treatment has been made in the literature. They act by inhibiting osteoclast activity and bone resorption. The bisphosphonate drug holiday can continue until there has been a “significant loss” of bone mineral density. 90 patients treated for 1-3 years. Until then, bisphosphonates should be used carefully. After 3 years of zoledronate therapy, in women who had a total hip T score above −2.5, no recent incident fracture and no more than one risk factor (almost 55 % of the population), risk for subsequent fracture (over three additional Osteoporosis itself is asymptomatic and often remains undiagnosed until a fragility fracture occurs. Reconsider the need to continue bisphosphonate therapy after 5–10 years in postmenopausal women and men over the age of 50 with osteoporosis who have responded well to treatment (T-score ≥–2.5 and no recent fractures). Discontinue after 5-7 years if the fracture risk is low. The recommended treatment regimen is 40 mg once a day for six months. Re-treatment with Alendronate sodium tablets may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Bisphosphonates persist in the bones for years, so 3 to 5 years of therapy is enough for many patients. The dose is 5mg given once a year, discontinuing after 3-5 years if your fracture risk is low. Bottom-line: Available evidence suggests that after 5 years of treatment, discontinuation of bisphosphonates carries little to no increased future fracture risk. Available evidence suggests that after 5 years of treatment, discontinuation of bisphosphonates does not increase fracture risk. Experts currently recommend stopping bisphosphonates after 3-5 years of use for a “holiday” that can last 1-or-more years (depending on the bisphosphonate used). IV zoledronate is an alternative option, given every 18 to 24 months for 3-4 doses, then every 3 years if T-score remains worse than -2.5. Thus, the data looked reassuring with respect to The bone turnover markers CTX, PINP, and BSAP, measured in 76 women who took part in the FLEX trial, did not predict bone loss at the lumbar spine, total hip, or femoral neck over a 5-year treatment-free period in women who discontinued ALN after a mean of 5 years. The good news is that the beneficial effects of 5 years woth of taking a bisphosphonate are seen 5 years after stopping! Recommendation 17. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. References BNF 74, September 2014. Most evidence supports continuing treatment long term, i.e. In the FLEX study, continuation of alendronate for 10 years instead of stopping after 5 years decreased nonvertebral fractures only in women whose femoral neck T-score was ˗2.5 standard deviations (SD) or less at the time of density (BMD) every 3-5 years. This risk varies depending upon your individual condition and treatment. The rate of vertebral fractures was not higher in patients after stopping denosumab (5.6 per 100 patient-years) compared to the previous placebo group (9.3 per 100 patient-years). After 5 to 10 years of oral treatment, consider a 1-2 year holiday. [3] Bisphosphonates are generally safe and well tolerated. after 5 years treatment with alendronate, risedronate or ibandronate Or after 3 doses of zoledronic acid Or post fracture Consider referral to primary care nurse specialist (where available) or secondary care osteoporosis service if: Thus, stopping bisphosphonate therapy after five years may be reasonable for some low-risk women (eg, no history of fracture and T-scores better than -2.5) as long as they are followed carefully by BMD and assessment of risk factors. In those on oral bisphosphonate with PINP > 35 μg/L, a change to IV is often indicated. Continuation of bisphosphonate treatment beyond 3-5 years (3 years for zoledronic acid and 5 years for alendronate, ibandronate and risedronate) can generally be recommended in the following situations: Age 75 years or more Previous history of a hip or vertebral fracture Occurrence of one or more low trauma fractures during treatment, after exclusion of poor adherence to treatment (for example less than 80% of treatment has been taken) and after … 30 This duration of effect can be partly accounted for by the strong binding to hydroxyapatite, the accumulation of 30 It is recommended that individuals take a drug holiday from a bisphosphonate after 5 to 7 years. The guidelines, published in the January 2016 issue of the Journal of Bone and Mineral Research, recommend reassessing a woman's fracture risk after five years of oral bisphosphonates or three years of IV therapy. I am very healthy 77 years old, swim, pilates, cycle etc., and really fed up with the medication. U Many patients who have had 5 years of continuous treatment with an oral bisphosphonate will have ongoing benefit for a further 5 years after cessation of the bisphosphonate. The 5-year cumulative incidences (risks) of hip fracture were 23.0 and 20.8 per 1000 individuals if women stopped taking bisphosphonate at study entry or after 2 additional years of treatment when allowing a 6-month grace period (Table 2). Use bisphosphonates for a 3 to 5 year period and then stop. RANKL agents such as Prolia can be used up to 10 years… Individual bisphosphonates have different indications and are used: 1. for the prevention and treatment of osteoporosis in postmenopausal women 2. for treatment of Paget’s disease of bone 3. as part of some anticancer treatment regimens, particularly for metastatic bone cancer and multiple myeloma The oral bisphosphonate medicines prescribed in the UK are: 1. ale… Because the medication lasts in the bones for some time after you stop taking it, your doctor might recommend stopping bisphosphonates after three to five years — especially if your overall risk of fracture is low. The incidence rate of oesophageal cancer over 5 years in men and women aged 60 to 79 years in the general population is 0.5 women per 1000 and 1.5 … This is related to accumulation of the bisphosphonate A ‘drug holiday’ refers to a temporary interruption of the osteoporosis treatment with BP, and then reintroducing it after a period of rest. Because there is no benefit to reduce fractures beyond 5 years, it is logical to stop alendronate after 5 years in most patients. holiday”. Your doctor can advise you and discuss the options with you. Patients considered at high fracture risk should either continue denosumab therapy for up to 10 years or be In men with osteoporosis, new malignancies were reported in no patients in the placebo group and 4 (3.3%) patients in the Prolia® group. “These results suggest no significant advantage of continuing drug therapy beyond 5 years,” according to agency’s 45-page review of scientific evidence. The NNT over three years to prevent one vertebral fracture is 14–20, and at least 91 to prevent one hip fracture. Dr. Lane recommends that patients taking bisphosphonates stop after 5 years. Osteoporosis - prevention of fragility fractures: Summary. This is related to accumulation of the bisphosphonate Zolendronic acid is given through an IV at your doctor’s . However, risk of spontaneous fracture after only 1 shot is negligible. If you are having intravenous bisphosphonates (injections), you have a higher risk of complications after surgery, ranging from 1 in 7 patients to 1 in 20 patients. There was no difference in the cumulative risk of nonvertebral fractures between the two groups, although the study design was not adequate for the assessment of this outcome measure (BLACK, … If you are having intravenous bisphosphonates (injections), you have a higher risk of complications after surgery, ranging from 1 in 7 patients to 1 in 20 patients. Discontinuing bisphosphonate therapy is associated with a rapid decline in atypical femur fracture risk, going from 4.5 fractures per 10,000 women in current users to 1.8 per 10,000 one year after stopping the medication and 0.5 per 10,000 2 years after stopping. 6.6.2 Bisphosphonates and other drugs affecting bone metabolism. After 3 to 5 years of treatment, reevaluate people at low risk for fracture, and consider discontinuing treatment. Most women who take bone-building drugs like Fosamax can safely stop taking them after five years, the Food and Drug Administration said Wednesday in a staff report leading up to a broad safety review scheduled Friday by two scientific advisory committees. U Some patients with very low [2] Bisphosphonates have been the most wide-ly used agent in South Korea (about 80%) for the treatment of osteoporosis. In some subgroups of patients at higher risk for fracture, continuing bisphosphonate use beyond 3-5 years has achieved additional reductions in vertebral fracture risk. reduce, and the risk of some very rare side effects increases. To minimize fracture incidence, consideration should be given to stopping bisphosphonates (a bisphosphonate holiday) after about 3 to 5 years of use in patients with osteoporosis (by DXA scan) but few or no other risk factors for bone loss (3 years for IV zoledronic acid and 5 years for oral bisphosphonates) They found that over a year … That's because after taking a bisphosphonate for several years, the medicine remains in your bone. JAMA 296 , 2927–2938 (2006). Recommendation 17. For patients at low risk, a decision to discontinue denosumab could be made after 5years, but bisphosphonate therapy should be considered to reduce or prevent the rebound increase in bone turnover. little ongoing benefit of bisphosphonates in the 5 years after an initial 5 years of treatment, particularly if their T score is above -2.5 at the end of the first 5 years. The guidance is really that you want to relook at the patient. For those taking a bisphosphonate, and are benefiting, I would recommend stopping after 4-5 years unless your doctor believes that you are at a … Mild Risk of Fracture. Until then, bisphosphonates should be used carefully. vol. After 5 to 10 years of oral treatment, consider a 1-2 year holiday. N Engl J Med. We should be considering stopping bisphosphonates in low risk individuals after 3-5 years of therapy. Denosumab (Prolia) works differently and when it is A causal relationship to drug exposure has not been established. This is a case of labeling catching up with the evidence. Can I PLEASE stop taking them? With respect to bone mineral density (BMD), alendronate, ibandronate, risedronate and zoledronic acid have been shown to increase BMD by 5-7% and 1.6-5% in the spine and femoral neck respectively after 3 years of treatment Black, D.M., et al., Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Gro It may also be that taking them for longer than five years does more harm than good. Bisphosphonate medications stay in your body for long . Men and women with established osteoporosis have a high risk of fragility fractures within the 5 yr after diagnosis, and in these cases the proven benefits outweigh the theoretical long-term risks. I just hope that someday these after-Prolia side-effects stop! New labeling will suggest STOPPING bisphosphonates (alendronate, etc) after 3 to 5 years in some patients at low fracture risk. Long-term use of bisphosphonates (especially alendronate) has been associated with subtrochanteric femoral cortical stress reaction. Bisphosphonates should then be resumed if bone mineral density (BMD) decreases or 2006;296(24):2927–2938. Also, the period advised for re-evaluation of fracture risk of 2–3 years after cessation of bisphosphonates is most likely too long after stopping denosumab. Bisphosphonates have a long half-life in bones and their anti-fracture efficacy continues for some years after stopping. Men and women with established osteoporosis have a high risk of fragility fractures within the 5 yr after diagnosis, and in these cases the proven benefits outweigh the theoretical long-term risks. WHAT IS THE EVIDENCE? 5 years ago I stopped calcium supplements and I am getting my calcium from food only. [If BMD remains low (T-score ≤–2.5) and/or there are incident vertebral fractures, continue treatment. “This is not like many drugs we use,” he said. Bone renewal is a slow process, but in many people an increase in bone density can be measured over five years of treatment. 1 The risk of atypical subtrochanteric fractures increases with the duration of bisphosphonate exposure. What you need to know The long term benefit and harm of management to continue or stop bisphosphonates after five years is incompletely... Offer high risk patients continued prescription, and low risk patients a drug holiday However, since the optimal bisphosphonate regimen post-denosumab is currently unknown continuation of denosumab can also be considered until results from ongoing trials become available. This risk varies depending upon your individual condition and treatment. In those on oral bisphosphonate with PINP > 35 μg/L, a change to IV is often indicated. Stopping after two or more shots puts you at risk. Adults who have been taking zoledronic acid for 3 years or alendronate, ibandronate or risedronate for 5 years should have a review of the need for continuing treatment. The American Society for Bone and Mineral Research has published recommendations for long-term bisphosphonate treatment, 1 in which they suggested that after 5 years of oral or 3 years of intravenous bisphosphonate treatment, one should consider reassessing fracture risk. after Aclasta infusions or 5 years of bisphosphonate therapy, unless bone density is above the osteoporotic level, i.e. [National Osteoporosis Guideline Group's Clinical guideline for the prevention and treatment of osteoporosis, section 7, recommendation 6] Weinstein, RS. A drug holiday is not recommended for denosumab. Prolia, however, is not as strong a medication as Forteo™ or Evenity™. I was treated for breast CA nearly 10 years ago, and after all that time have now been diagnosed with metastatic CA, though it’s been hiding all these years (long story). Accessed via: https://bnf.nice In hospital for 7 weeks !! 55 A medication ‘holiday’. Since bisphosphonates may remain in the skeleton for years, it should be kept in mind that there is also the potential for adverse effects after stopping bisphosphonates. It affects 10 million Americans; another 34 million are considered at risk.1 After that interval of 3–5 years, the decision about whether to continue or to temporarily discontinue bisphosphonates can be addressed as has been suggested by several authors [22–24]. Bisphosphonates are a group of drugs that work by slowing bone loss. In FLEX, a significant reduction in the risk of clinical vertebral fractures was shown in patients who continued alendronate for 10 years compared to those who stopped the treatment after 5 years. Consider stopping oral Bisphosphonates after 5 years (or 8-10 years if multiple Vertebral Fractures) Consider stopping Reclast after 3 years (or 6 years if multiple Vertebral Fractures) Consider stopping especially if no history of osteoporotic Fracture; Restarting bisphosphonate. Discuss a recent large cohort study specifically designed to understand the risks vs. benefits related to continuing or stopping bisphosphonate treatment beyond 5 years. Speak with your health care provider about your fracture risk before stopping any drug. For patients taking bisphosphonates for 3 to 5 years, reassess the need for ongoing therapy. Women who should consider a holiday after about 5 years on a bisphosphonate pill include those whose risk of fracture is now lower because their bone density has … Since then, several case reports have clearly taken note of this and documented longer periods of bisphosphonate use (Table 1 ). Based on available evidence, it is advised that a re-evaluation should be performed after 5 years of denosumab treatment. [Drugs: alendronate, risedronate, ibandronate and zolendronate] Long term use and possible side effects Long term use of oral bisphosphonates is not without its risks. T score above -2.5. These findings 6,7 Even after they are discontinued, bisphosphonates affect 8 A ‘drug holiday’ refers to a temporary interruption of the osteoporosis treatment with BP, and then reintroducing it after a period of rest. Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. MHRA Drug Safety Update (December 2015): Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal Because of this lingering effect, most experts believe that it's reasonable for people who are doing well during treatment — those who have not broken any bones and are maintaining bone density — to consider taking a holiday from their bisphosphonate after taking it for five years. Bisphosphonate treatment is not needed. And women who stop taking the drugs after five years have similar levels of increased bone density and reduced fracture risk as those who continue taking them, it said. Bisphosphonates accumulates in bone & their residual benefit in terms of fracture reduction persists for some time after a 3-5 year course of bisphosphonate treatment. Treatment is now in many patients stopped after five years as this is what is advised in low risk patients on bisphosponates while physicians do not always realise that in contrast to stopping bisphosphonates there is a very rapid increase in bone turnover and decrease in BMD after stopping denosumab because the drug is not retained in bone. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. How to start and stop bisphosphonates. Your bone density, your age, your history of fractures and other factors determine your risk. This has led to the concern that long term treatment may increase bone fragility by … These risks are rare, but include: Breaking a thigh bone, Problems with the health of your jaw. September 7, 2011 2:52 pm. 20 reported the changes in BMD after stopping a 3-year course of risedronate 5 mg/day in 293 women with postmenopausal osteoporosis. So 3 to 5 years is enough for many patients...because benefits seem to last even after treatment is stopped. 70% over 3 to 5 years of treatment. 4 Bisphosphonate treatment review Timing of review: after 5 years treatment with alendronate, risedronate or ibandronate Or after 3 doses of zoledronic acid Or post fracture Consider referral to primary care nurse specialist (where available) or secondary care osteoporosis service if: a. taken with these medications. Thus, stopping bisphosphonate therapy after five years may be reasonable for some low-risk women (eg, no history of fracture and T-scores better than -2.5) as long as they are followed carefully by BMD and assessment of risk factors. Some suggest stopping bisphosphonates after 5 years in lower-risk patients (eg, those without previous fractures) 8; however, this subgroup selection is not based on RCT evidence. “Glucocorticoid-induced bone disease”. Reconsider the need to continue bisphosphonate therapy after 5–10 years in postmenopausal women and men over the age of 50 with osteoporosis who have responded well to treatment (T-score ≥–2.5 and no recent fractures). Bisphosphonates have a long half-life in bones and their anti-fracture efficacy continues for some years after stopping. Siamang in reply to antiP2219 2 years ago. no contraindications or intolerance for a further 5 years. Mild risk of fracture: treat with bisphosphonate for 3–5 years, then stop. Bisphosphonates accumulates in bone & their residual benefit in terms of fracture reduction persists for some time after a 3-5 year course of bisphosphonate treatment. acid after 3 years, Alendronate, Ibandronate, or Risdronate after 5 years: o People who remain at high risk of an osteoporotic fragility fracture: continue treatment with Alendronic acid for up to 10 years, and risedronate for up to 7 years. Stop using alendronate and call your doctor at once if you have: chest pain, new or worsening heartburn; difficulty or pain when swallowing; pain or burning under the ribs or in the back; severe heartburn, burning pain in your upper stomach, or coughing up blood; After 5 years … Bisphosphonates have a long latency period, with a suggested terminal half-life of 10.5 years for alendronate. little ongoing benefit of bisphosphonates in the 5 years after an initial 5 years of treatment, particularly if their T score is above -2.5 at the end of the first 5 years. If your high-risk patient has been on bisphosphonates for long term, consider a drug holiday of one to three years, or until there is significant loss of BMD or the patient has a fracture, whichever comes first. After 3-5 years of bisphosphonate therapy, patients at low fracture risk can consider a “drug holiday,” whereas patients at high risk (T-score <−2.5, prior vertebral fracture) should continue to be treated and followed to 10 years. 1 Often there is prodromal pain for weeks to years. Almond milk, cheese… When I switched to MK4, 5 mg 3x a day, that problem disappeared and I immediately noticed that right-sided sinus congestion I'd had for many years went away--for just 8 hours. And after taking This may involve some tests to check the strength (density) of your bones. Low (<10%) NO indication for bisphosphonates - Moderate (10 to 20%) Without recent Fxs Between 5 and 7 years 1 to 3 years depending on bisphosphonate used Risedronate< Alendronate< Zoledronic Acid High (>20%) Recent Fxs, Hip or Vertebral Fxs Do not stop therapy or switch to another class of agents Monitor for adverse events Stop using Fosamax and call your doctor at once if you have: chest pain, new or worsening heartburn; difficulty or pain when swallowing; pain or burning under the ribs or in the back; severe heartburn, burning pain in your upper stomach, or coughing up blood; Bisphosphonate treatment should be discontinued and not resumed until the patient meets treatment guidelines. 2011. pp. Consider repeat DEXA Scan every 2 years for monitoring Objective To compare the effects of discontinuing alendronate treatment after 5 years vs continuing … Then I would have to take it again. Low risk of fracture: treatment is not needed. After stopping denosumab therapy, three women sustained a single, symptomatic vertebral fracture between 1 and 3 years after the last injection, for a rate of 1.1 per 100 patient-years… Unlike anabolic agents limited to 2 years, on can stop a bisphosphonate after a few years and it will continue to work for up to several years after stopping. [Drugs: alendronate, risedronate, ibandronate and zolendronate] Long term use and possible side effects Long term use of oral bisphosphonates is not without its risks. Bisphosphonates can be taken by mouth Advise patients taking bisphosphonates for many years to talk to their prescriber about possibly stopping the drug. They reduce the risk of hip and spine fractures. You may be able to discontinue therapy with bisphosphonates after 5 years of use if your fracture risk is low. Continue to follow up with your doctor for monitoring and repeat bone density scans about every 1-2 years; your doctor will decide how often the test should be repeated. Bisphosphonates: Continuing or Stopping after 5 years •1999 postmenopausal women previously randomised to alendronate in FIT trial, average 4 years of previous treatment •Randomised to continue or cease alendronate 9 10 For this reason, your doctor will look at the benefits and risks of your treatment after 3 to 5 years and decide whether you should keep taking alendronic acid. Bisphosphonates persist in the bones for years. o Medium risk patients require assessment of BMD for consideration of a treatment break (“drug holiday”) of 2 years for oral bisphosphonates. This pain normally goes away after you stop taking a bisphosphonate. The serum formation markers were somewhat different; P1NP increased moderately but was still 24% below baseline 5 years after stopping, whereas the BAP gradually increased towards baseline. The choice of treatment should be made on an individual basis after discussion between the responsible clinician and the patient, or their carers, about the advantages and disadvantages of the treatments available. I quit bisphosphonates after having taken Actonel for 2+ years, and refused my oncologist’s recommendation of Xgeva when the metastasis was discovered recently. 62-70. o Some suggest stopping bisphosphonates after 5 years in lower risk patients, such as those without previous fractures.7 This subgroup selection is not based on RCT evidence. After 10 years the benefits of taking bisphosphonates. After stopping treatment, all three groups showed an increase in BTMs and a decrease in hip BMD; however, none returned to pre-treatment baseline values. My advice don’t take them after 5 years !!! Such a mess. 365. I pray you are right about stopping after 1 shot. If certain subgroups should continue therapy beyond 5 years and when or if therapy should be reinitiated remains uncertain. No consensus exists regarding optimal duration of bisphosphonate therapy. The terminal half-life of alendronate is similar to that of bone mineral, approximately 10.5 years.7 Thus, some of the skeletal effects of alendronate and other bisphosphonates may last for years after treatment stops. The task force guidance specifies that all patients be reassessed after 5 years of oral bisphosphonates or 3 years of intravenous bisphosphonates, and a drug holiday can …