A failure to observe an increase in BMD during therapy with bisphosphonates, denosumab or raloxifene does not indicate decreased anti-fracture efficacy of the drug and is no indication to change treatment.10–15 A stable or increasing BMD during treatment with most agents currently approved for osteoporosis therapy should be considered as adequate response to therapy.10–15 In contrast, detectable loss of BMD while on anti-resorptive treatment may be associated with negative clinical outcomes (increased fracture risk) and should prompt review of both diagnosis and treatment regimen.16–18
A decision to change treatment solely on the basis of a fracture occurring during treatment is not supported by randomised controlled trial data. As fractures will occur in some individuals even on effective therapy, fracture per se is not an indication to change. However, patient tolerance, compliance and side effect profile may suggest changing the type or route of administration of therapy on an individual basis. Evidence of lack of response (eg falling BMD or failure to achieve expected changes in bone-turnover markers) could justify a change. However, compliance with, and the correct mode of, taking medications should be evaluated first, as problems with one or other of these aspects is the most likely explanation. Although long-term compliance with non-pharmacological and pharmacological interventions is a principal goal of any osteoporosis therapy, it usually is low, even in patients with established fractures.19,20
Follow-up visits, close contact between patient and health professionals, as well as repeat BMD and/or bone-marker measurements, may be used to improve medication adherence. In a British study, review of the results of serial BMD and/or bone-marker measurements between nurse and patient, or doctor and patient, resulted in improved adherence to and persistence with medication.21 However, currently there is no consensus on the use of surrogate parameters to increase adherence. Three major international guidelines recommend follow-up to ensure that treatment is effective. Regular monitoring is an important component of any osteoporosis treatment plan.22–24 This applies to patients both with and without anti-osteoporotic drug treatment. Follow up BMD testing and physician check-ups are also recommended.22,23,25
Patients with an increased risk of fracture in the initial examination should be re-evaluated in terms of the implementation of non-pharmacological measures, risk factors and the future development of fracture risk in intervals adequate to the risk in question. Because a decrease in BMD below the measurement error before a time of two years is unlikely, follow-up examinations of BMD are usually not recommended at intervals of less than two years.22 The use of repeat DXA scans at intervals of two years or longer is appropriate in settings where the efficacy of treatment, risk assessment or decision to change or interrupt treatment is being considered.18,26 Repeat scans may also be useful for addressing patients’ concerns in relation to treatment adherence.23 If carried out less than two years after commencing treatment, the changes may be difficult to interpret unless the change is greater than 2.8 x precision (eg standard deviation or coefficient of variation of repeat measurements).
After initiating a specific pharmacological intervention, clinical examinations are recommended after 3–6 months and after 6–12 months. This may include documenting pain, functionality, weight and height.22 Conduct ongoing monitoring of patients taking medication, particularly those taking bisphosphonates, to ensure compliance with administration instructions. Laboratory tests may be used to identify drug induced side effects or potentially treatable conditions contributing to the patient’s skeletal disease.