Long-term persistence with denosumab: real-world data from the Austrian Osteoporosis Clinic (AOC). A retrospective data analysis.

In short-term studies, persistence with denosumab has been higher than with other osteoporosis drugs. This study shows that persistence can be maintained in the long-term and is associated with efficacy and safety parameters. PURPOSE: To assess long-term persistence with denosumab in postmenopausal women with osteoporosis. Secondary purposes were the evaluation of changes in efficacy and tolerance/safety parameters over time. METHODS: Persistence was determined by number and rate of patients receiving denosumab on time in 6-month intervals (+ / - 8 weeks). The total population was stratified by internal patients (injections and monitoring at the Austrian Osteoporosis Clinic [AOC], 74%) and external patients (injections at the practitioner's office with occasional monitoring at the AOC, 26%). In internal patients, efficacy parameters including bone mineral density (BMD) and the bone marker CTX were assessed at fixed time points and tolerance/safety parameters including side effects (SEs), adverse events (AEs), and serious AEs (SAEs) evaluated. RESULTS: Of 851 patients, 71% (73% internal and 64% external) were persistent at 7.5 years of follow-up. The mean rate of cumulative persistence in internal patients decreased from 94% at the time of the second dose to 73% at the time of the fifteenth dose. BMD increased and CTX decreased, overall and in pairwise comparisons (all p < .001). AEs and SAEs, but not SEs, were lower in persistent than non-persistent patients. CONCLUSIONS: This is the first study showing that long-term (> 3 years) real-world persistence with denosumab could be maintained at a high level (> 70%) in most patients. Denosumab was well tolerated and associated with decreased CTX levels and increased BMD.

Bone turnover markers in serum but not in saliva correlate with bone mineral density.

Saliva was proposed as a diagnostic tool for systemic diseases. Here we determined the correlation of bone turnover markers in saliva, bone turnover markers in serum and bone mineral density in postmenopausal osteoporotic and healthy women. Forty postmenopausal osteoporotic and 40 age-matched healthy non-osteoporotic females were recruited for this case-control study. Serum and stimulated saliva levels of osteocalcin, N-terminal propeptide of type I collagen, bone-specific alkaline phosphatase and cross-linked-C-telopeptide of type I collagen were determined. Bone mineral density of the lumbar spine, proximal femur, and total hip were obtained. We show that osteocalcin and cross-linked-C-telopeptide of type I collagen (CTX) reached detectable levels in saliva while N-terminal propeptide of type I collagen and alkaline phosphatase were close or below the detection limit. Serum levels of bone turnover markers were significantly higher than saliva levels. Correlation analysis revealed a strong correlation of serum osteocalcin and, to a lesser extent, also serum CTX values with bone mineral density in lumbar spine, femoral neck, or total hip, respectively. There was, however, no significant correlation of bone mineral density with the respective bone turnover markers in saliva. There was a trend that saliva osteocalcin correlates with femoral neck (p = 0.16) or total hip (p = 0.06). There was also no association between serum and saliva bone turnover markers. This study reveals that saliva cannot replace the withdrawal of serum to evaluate bone metabolism.

User experience with an oral contraceptive containing ethinylestradiol 30mug and drospirenone 3mg (yasmin((r))) in clinical practice.

OBJECTIVES: To assess the reasons why women chose the combined oral contraceptive (COC) containing ethinylestradiol 30mug and drospirenone 3mg, their perception of it, and their satisfaction with it when used in clinical practice. METHODS: This was an uncontrolled survey of women using the ethinylestradiol 30mug/drospirenone 3mg COC in 15 European countries from September to December 2004. The women were invited to participate in this study by their general practitioner, gynecologist, or other family planning provider. The women were asked to complete a four-part questionnaire retrospectively about why they chose the ethinylestradiol 30mug/drospirenone 3mg COC and their experiences with it. RESULTS: A total of 10 947 questionnaires were returned and included in the analysis. Of the respondents, 7694 (70%) had switched to the ethinylestradiol 30mug/drospirenone 3mg COC from other oral contraceptives. About two-thirds (6797 [62%]) of respondents stated that they felt better while using the ethinylestradiol 30mug/drospirenone 3mg COC compared with the time before they started using it. The severity of premenstrual symptoms including depressed mood, irritability, breast tenderness or pain, abdominal bloating or swelling, skin and hair problems, and swelling of the extremities all improved during treatment with the ethinylestradiol 30mug/drospirenone 3mg COC. Overall, 10 441 (95%) respondents were satisfied or very satisfied with the ethinylestradiol 30mug/drospirenone 3mg COC and 9016 (82%) would recommend it to a friend. CONCLUSION: The additional non-contraceptive benefits of the ethinylestradiol 30mug/drospirenone 3mg COC are important factors that influence patients' perceptions of this oral contraceptive and their satisfaction with its use.