After considering major randomized controlled clinical trials, a task force of the American Society for Bone and Mineral Research has released guidelines on the optimal duration of bisphosphonate therapy for osteoporosis. The guidelines, published in the January 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.
They advise that women whose risk is still high should continue to take oral bisphosphonates for up to 10 years or IV therapy for up to six years. However, fracture risk should be reassessed every two to three years during extended therapy. For women determined to be at low risk after five years of oral therapy or three years of IV therapy, treatment may be discontinued, but fracture risk should be reassessed periodically. Guidelines are only advice, not mandates.
If you are at high risk for a fracture of the hip or spine, the decision to take—or to continue taking—a bisphosphonate is one to make with your doctor after considering your general health, the potential risks and benefits of the medication, and your preferences. As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles.
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Fracture rates were reported but were not primary outcomes in any of the trials. However, the authors noted that fractures were reported as secondary outcomes and that the trials were not adequately powered to determine fracture risk. Patients were randomized to alendronate, 5 mg per day for two years, then 10 mg per day for the remainder of the trial, or placebo.
Treatment was continued for four years, then participants were stratified by baseline T-scores for subgroup analysis. There was no significant difference in fractures when comparing the whole treatment group to the control group.
This conclusion is limited by the small numbers of fractures in the trial and by the nature of post-hoc analyses, in which final data are reexamined in ways that were not intended in the initial study design. Already a member or subscriber? Log in. Interested in AAFP membership? Learn more. Address correspondence to Julia M. Shaver, MD, at Julia. Elsevier; Ferri FF. In: Ferri's Clinical Advisor Goldman L, et al. In: Goldman-Cecil Medicine.
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Ultrasound Show more related content. Mayo Clinic Press Check out these best-sellers and special offers on books and newsletters from Mayo Clinic. Legal Conditions and Terms Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Unlike all the other drugs used to treat osteoporosis, the effects of bisphosphonates on bone remodeling persist after stopping therapy.
Knowledge of these properties prompted studies to evaluate the duration of effects on bone remodeling, bone mineral density, and fracture risk upon stopping treatment, beginning with the early phase 2 and phase 3 studies with alendronate and risedronate and continuing until the extension of the most recent phase 3 bisphosphonate fracture study, the HORIZON trial with annual intravenous dosing of zoledronic acid [ 2 — 11 ].
The initial studies with alendronate demonstrated gradual decreases in BMD and increases in biochemical markers of bone turnover toward baseline values over several years [ 2 — 8 ]. In contrast, resolution of the effects of risedronate on bone mineral density and bone turnover within 1 year was reported [ 9 , 10 ]. At the other end of the spectrum, minimal changes in both BMD and turnover markers were observed in the first 3 years upon stopping annual intravenous zoledronic acid therapy after three doses [ 11 ].
The more limited information about the effects of discontinuing therapy on fracture risk suggests that, after 3—5 years of treatment, protection from fracture persists for 1—2 years and then gradually wanes [ 8 , 9 , 11 , 12 ]. These studies have evaluated the off effects of therapy after exposure of 2 to 5 years in clinical trial settings.
Although interesting, this information is of limited relevance to the majority of patients in daily practice since most patients discontinue oral bisphosphonate therapy within the first few months of treatment, the average duration treatment being only a few months [ 13 ].
They monitored fracture rates in subgroups stratified by treatment duration and by time off therapy. These rates were then compared to those observed in patients who took their prescribed drug for less than 1 month. The authors observed that the patients taking oral alendronate and risedronate for at least 1 year had lower rates of fracture after stopping therapy that did the control group. However, this fracture protection was only evident during the first 6 months after treatment was stopped.
While there were trends toward better fracture protection beyond 6 months after stopping in patients who received treatment for more than 1 year, those effects were not statistically significant. These analyses are limited, of course, by a relatively small sample size and limited statistical power. No differences in the effects of alendronate or risedronate on the magnitude or duration of fracture protection were noted. There are several clinical messages in these interesting data.
The observations confirm the suspicion that taking an oral bisphosphonate for less than 6 months has little effect on fracture risk, and that treatment for less than 1 year is suboptimal compared to longer-term treatment. These results conform to clinical trial data that consistently demonstrate a reduction in vertebral fracture risk within the first 12 months of bisphosphonate therapy whereas the more modest effects on non-vertebral and hip fracture incidences are generally not observed until exposure of more than 1 year [ 15 — 18 ].
It would be helpful to know both the median duration and the ranges of bisphosphonate exposure in this group in the study. Based on previous clinical trial data, there appears to be no greater effect on fracture risk with long-term bisphosphonate treatment more than 3 years compared to shorter-term treatment 1—3 years [ 11 , 19 ].
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