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RCT of adherence in osteoporosis

Clinical bottom line

In a small clinical trial, there was a limited effect of monitoring older women treated for osteoporosis in improving adherence to treatment.

Background

Long term use of antiresorptive therapy in older women with osteoporosis is poor. The reasons may be due to adverse events to some extent, but the condition is a symptomatic, and it is the reduction in risk of possible future fractures that is being treated. There is no positive feedback. Giving patients feed back from biochemical monitoring was tested in this trial.

Reference

JA Clows et al. The impact of monitoring on adherence and persistence with antiresporptive treatment for postmenopausal osteoporosis: a randomised controlled study. Journal of Clinical Endocrinology & Metabolism 2004 89: 1117-1123.


Study

The patients were 75 healthy postmenopausal women aged 50-80 years. They had low bone mineral density at spine or hip. At screening before the start of the study, as well as a clinical assessment, several fasting morning urine samples were collected for measurement of bone turnover markers.

Women were randomised into three study arms:

  1. No monitoring (usual care)
  2. Nurse monitoring (attention)
  3. Marker monitoring (attention plus information)

All the women received raloxifene 50 mg daily and calcium 500 mg daily, prescribed at 0 and 24 weeks. In the usual care group, women attended to collect the repeat prescription. In the attention group and marker monitoring group they attended at 12, 24 and 36 weeks, and this included a pre-defined interview with questions about well being, the medicine, and adverse events. There was no question about compliance. The marker monitoring group provided urine samples four days before the visit, and were additionally shown a graph of their results, with interpretation.

The outcome was adherence, collected through electronic monitoring devices recording the frequency and date of opening of medicine bottles. Adherent subjects were defined as those taking 75% of their prescribed medicine over one year.

Results

There were 25 women in each group, with a mean age of 63 years. Groups were similar at baseline. As many as four women had many more tablets removed from the container than the number of times the container was opened, suggesting tablet dumping.

The percentage of tablets taken averaged 75% or more in all three groups, but the no monitoring group had a significantly higher rate of nonadherence (58% vs 33%). Monitoring by nurse with or without markers improved compliance compared with no monitoring

Comment

Though a very small trial like this is limited, and can not be extrapolated generally, the idea that positive feedback from professionals can improve adherence is interesting. We just need much more data before making more of the idea.