1 Based on patient surveys, common reasons for discontinuation include side effects, high price, and inconvenience. Black DM, Reid IR, Boonen S, et al. Compston JE, Bilezikian JP.
5, 24 On the basis of the annual review or repeat DEXA scan results, clinicians and patients may decide to re-initiate a bisphosphonate, e.g.
The risk of vertebral, hip, and other nonvertebral fractures was reduced in women with osteoporosis. Ibandronate that assessed either oral or intravenous dosing regimens was not continued in placebo-controlled design.
Bauer and colleagues recently evaluated the FLEX study in a post hoc analysis to test methods of predicting fracture risk among women who have discontinued alendronate therapy after four to five years.7 After four to five years of alendronate therapy, older age and low hip BMD at discontinuation predicted clinical fractures during the subsequent five years.
But no differences were observed in the number of nonvertebral fractures between the placebo and continued alendronate groups. The challenge is to be informative, assess your patients' risk of fracture on a regular basis, and do not overlook patients who have had a fracture.2. They indicated that patients that are at low risk for fractures, meaning those that are younger and without a history of fracture and a bone mineral density (BMD) near normal range, may be good candidates for bisphosphonate therapy lasting for 3-5 years. Bone mineral density (BMD) was the primary outcome measure with fractures assessed as exploratory endpoints or collected as adverse events. However, the extension trials had smaller numbers of subjects and were not powered for fractures as a primary endpoint. The mean serum levels of bone turnover markers measured remained within the premenopausal reference range in both groups. Eight of the 82 patients (9.8%) experienced one or more osteoporotic fractures during the 1-year observation study after stopping denosumab therapy. Implementation The relative benefit of bisphosphonates for fracture prevention is about 30% (range 20% to 50%). The incidence of osteoporotic fracture was 4.9% in patients who were receiving denosumab during years 5–8 of the phase 2 study . The long term benefit and harm of management to continue or stop bisphosphonates after five years is incompletely understoodOffer high risk patients continued prescription, and low risk patients a drug holidayA 74 year old woman experienced a low impact Colles’ fracture five years ago and was started on a bisphosphonate. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. Nelson Watts, MD, an internationally recognized endocrinologist, refers to this as a "data-free zone." 9. Overall, the nine-year study suggests a diminishing return from its ongoing administration. younger women, men or the very elderly).During the trial, there were no reports of osteonecrosis of the jaw. Osteoporosis is a disease associated with a reduction in bone mass and an increase in skeletal fragility. Appropriateness of continued therapy based on an individual’s risks and benefits should be assessed during the reevaluation period. Although newer antidepressants like Celexa are less likely to lead to adverse reactions while you’re taking them, when you quit it’s a totally different story. Leslie WD, Lix LM, Johansson H, et al. Although there was a statistically significantly lower risk of clinical vertebral fractures in the alendronate group (5.3% with placebo vs 2.4% with alendronate; RR, 0.45; 95% CI, 0.24-0.85), post hoc subgroup fracture analysis did not indicate any significant trends with lower BMD or prevalent vertebral fractures at FLEX baseline for either nonvertebral or clinical vertebral fractures. Results from the second randomized extension of HORIZON-PFT were recently released online.5 A total of 190 women on zoledronic acid for six years in the first extension study were randomized to either zoledronic acid or placebo for an additional three years. Available evidence suggests that after 5 years of treatment, discontinuation of bisphosphonates does not increase fracture risk. The FRAX tool (www.shef.ac.uk/FRAX/) may be helpful in assessing the need for continued treatment or treatment withdrawal. Bisphosphonates, the most commonly prescribed class of agent for the treatment of osteoporosis, have proven efficacy for prevention and treatment of bone loss and fractures due to aging, estrogen deficiency, and glucocorticoid use. It's something you'll need to discuss with your doctor and do what works for you. Expert opinion is based on limited data. The costs to the individual, the family, and society are significant.
Fracture reduction is the goal of long-term osteoporosis treatment. Decisions to stop or continue bisphosphonate treatment after 5 years (3 years for zoledronate) should be based on individual assessment of risks and benefits, following an informed discussion between the clinician and the individual patient.