Breast cancer and bone mineral density: the Marburg Breast Cancer and Osteoporosis Trial (MABOT II).

OBJECTIVES: The current case-control study is the first to examine the relationship between bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) and quantitative ultrasonometry (QUS) in pre- as well as postmenopausal women with breast cancer compared to healthy matched controls. METHODS: Among 1422 women (premenopausal, n = 238, postmenopausal, n = 1184), BMD and QUS were measured. In total, 541 of the women had an incident diagnosis of breast cancer (122 premenopausal, 419 postmenopausal) without prior breast cancer treatment. Because of significant intergroup differences in multiple risk factors, a matched-pair analysis (88 premenopausal and 402 postmenopausal women with and without breast cancer) was performed. Additionally, a multiple linear regression analysis was undertaken, odds ratios were determined and subjects grouped according to quartiles of DXA and QUS results. RESULTS: DXA results (except the L1-L4 Z-score) were significantly higher in postmenopausal women with breast cancer even after a matched-pair analysis was performed (p < 0.05). In premenopausal women, we observed no significant differences in DXA results between the groups. QUS results in pre- and postmenopausal women with breast cancer were significantly higher compared with their matched controls (p < 0.001 for all, except for speed of sound in premenopausal patients, p < 0.05). Odds ratios for breast cancer risk in the second, third and fourth quartiles compared with the lowest quartile were significantly different for a number of variables. CONCLUSIONS: Our results showed significantly higher BMD irrespective of the method and site of measurement in postmenopausal women with breast cancer compared to controls, even after matching for possible confounders for the first time.

Adherence and persistence in patients with postmenopausal osteoporosis treated with raloxifene.

OBJECTIVE: A major impediment in osteoporosis care is poor therapeutic adherence. Real-life surveys show that adherence and persistence with oral bisphosphonates decrease to 30-60% within 1 year. The aim of this study was to analyze the adherence and persistence with raloxifene in patients visiting our outpatient clinic. MATERIAL AND METHODS: A total of 342 patients were evaluated from the conventional osteoporosis practice receiving treatment with raloxifene. Patient self-reporting was combined with the medication possession ratio (MPR) assessed via prescription refill counts. In addition, persistence and other self-reported and patient file-based data were assessed. RESULTS: The final analysis comprised 300 patients with a mean age of 66.3 years (standard deviation ± 7.2 years). At 6 months 84%, at 12 months 81%, at 24 months 78% and at 36 months 77% of patients were persistent with therapy according to patients' self-reports. If MPR and self-reported data were combined, 56%, 48% and 35% of patients remained on therapy at 12, 24 and 36 months, respectively. The mean duration of therapy was 19 months with a mean MPR of 52.8%. Finally, 31.7% of all patients were classified as adherent. Significant correlation to adherence was found for tolerability and motivational factors. CONCLUSION: This study revealed that approximately half of the patients treated with raloxifene in regular clinical practice stay on therapy for the first 2 years. Furthermore, the patients do not adhere sufficiently to the recommended dosage, and reduced clinical efficacy in clinical practice is presumable. The reasons for non-adherence comprise tolerability and motivational factors but further investigation is needed.

Adherence and persistence in patients with severe osteoporosis treated with teriparatide.

INTRODUCTION: Medical intervention plays a key role in the treatment of postmenopausal osteoporosis and patients' adherence to therapy is essential for optimal clinical outcomes. While adherence in RCTs is usually around 70-90%, a previous study showed that in clinical practice only 27.8% and 46.5% of the women on oral daily vs. weekly alendronate were still on treatment after 12 months. Data on adherence to teriparatide (TPTD) treatment of severe postmenopausal osteoporosis are available from only few countries. This study assessed adherence and persistence with TPTD in Germany. MATERIAL AND METHODS: A sample of 50 women with severe postmenopausal osteoporosis treated with TPTD in accordance to the German osteoporosis guidelines was included. Treatment was initiated 12-24 months before recruitment. Patient self report was assessed using a validated questionnaire. In addition medication possession ratio (MPR) was calculated by counting prescription refills, and therefore all physicians who were treating the patients for any disease were contacted. Patients were classified adherent at 12 months of therapy if self-reported adherence and an MPR of > or =80% were achieved. Persistence was calculated in months and analysed with a Kaplan-Meier estimate. RESULTS: Apart from a significantly lower age at menopause in the adherent group (46.1 vs. 50.0; p < 0.006) there were no significant differences in baseline demographics between adherent and non-adherent patients. After 12 months, 80% of the patients treated with TPTD were adherent, while 20% were non-adherent. A significant correlation with treatment adherence was found for self-reported medication tolerability (p < 0.001). Furthermore 79% of patients were persistent after 12 months. CONCLUSION: These results indicate that more patients seem to be adherent and persistent with TPTD than with oral treatments of postmenopausal osteoporosis. As these patients suffered from severe osteoporosis and sustained several fragility fractures, the generalisability of our retrospective study analysing a small sample is limited. The major factor that reduced adherence and persistence was tolerability. These findings are of practical relevance as numerous studies on antiresorptive therapies have shown that high adherence and persistence were needed to ensure an optimal therapeutic outcome.