Osteoporosis prevention, diagnosis and management in postmenopausal women and men over 50 years of age

Recommendations

Ongoing monitoring

Evidence statement

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.

Grade: B

Recommendation 24
Regularly re-assess fracture risk and requirement for anti-osteoporotic therapy in patients who are not receiving therapy, but remain at increased risk of fracture.

Grade: B

Recommendation 25
Review all patients 3–6 months after initiating a specific pharmacological intervention for osteoporosis, and annually thereafter. Bone mineral density testing at the 3–6 month review is not indicated.

Grade: D – consensus

Recommendation 26
Biochemical markers of bone turnover should not be routinely used for the diagnosis of osteoporosis in general practice. Measurement of markers should be confined to specialist practice, and may be useful for the monitoring of adherence to treatment and in the evaluation of secondary causes of bone loss.

Frequency of re-assessment should be determined by the individual’s overall fracture risk and occurrence of any new health events. Vigilance should be exercised for height loss and new episodes of back pain.

At present, there are no validated criteria for the failure of medical therapy. However, therapeutic failure should be considered if:

  • ‘unexpected’ fractures occur (usually more than one fracture event), in which case other non-pharmacological measures need to be implemented or reinforced as required (refer to General bone-health maintenance and fracture prevention strategies  for more information)
  • there is a documented decrease in height of more than 3 cm since the last examination or acute back pain, which may be symptomatic of a new fracture – in these cases, a radiological examination is recommended.
  • A decrease in bone mineral density (BMD) greater than measurement error is generally not seen before two  years; hence, follow up bone densitometry is not recommended at intervals of less than two years.1,2
  • It is appropriate to recommend a repeat BMD test by dual energy X-ray absorptiometry (DXA) after two years for patients at risk of developing osteoporosis, to assist in re-evaluation of fracture risk.
  • In patients with confirmed osteoporosis, a repeat BMD test is generally not required, but may be conducted before initiating a change in, or cessation of, anti-osteoporotic therapy.
  • Wherever possible, perform repeat BMD tests on the same instrument or at least the same type (manufacturer and model type) of instrument, to improve comparability of results in interpreting any change in BMD.
  • Changes of <5% at the lumbar spine or hip are within the precision error of most DXA machines and therefore should be regarded as representing no significant change.
  • A radiographic assessment should be initiated if new fractures are suspected (eg height loss of 3 cm or more, new or acute pain).

Biochemical markers of bone turnover decrease rapidly (within three months) after initiation of anti-resorptive drugs such as oral or intravenous (IV) bisphosphonates, denosumab or raloxifene.3–5 They have also been shown to provide some prognostic information on the anti-fracture efficacy of these agents.6–8 Therefore, bone-turnover markers may be used at three and 12 months to assess the effect of alendronate, risedronate, zoledronic acid, denosumab or raloxifene on bone metabolism. Values of procollagen type I amino-terminal propeptide (PINP) increase soon after commencement of anabolic teriparatide therapy.9

Although the role of bone-turnover markers in monitoring osteoporosis treatments has not yet been fully investigated, measuring a bone resorption marker after three months of anti-resorptive treatment and finding a level in the lower half of the premenopausal range indicates compliance with therapy. However, in the absence of clear evidence of improved patient outcomes from their use, as well as cost-effectiveness data, their routine use in patient monitoring in general practice is not currently recommended.

Related documents

  Osteoporosis-flowchart.pdf (PDF 0.98 MB)