Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate
| Autor: | D L, Kendler, M R, McClung, N, Freemantle, M, Lillestol, A H, Moffett, J, Borenstein, S, Satram-Hoang, Y-C, Yang, P, Kaur, D, Macarios, S, Siddhanti, Jerieta, Waltin-James |
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| Rok vydání: | 2010 |
| Předmět: |
medicine.medical_specialty
Treatment adherence Injections Subcutaneous Endocrinology Diabetes and Metabolism Osteoporosis Administration Oral Antibodies Monoclonal Humanized compliance Medication Adherence law.invention Randomized controlled trial Bone Density law Internal medicine Clinical endpoint medicine Humans adherence Osteoporosis Postmenopausal Aged Postmenopausal women Alendronate Bone Density Conservation Agents British Columbia business.industry Alendronic acid Antibodies Monoclonal Patient Preference persistence Middle Aged medicine.disease Rheumatology Surgery Treatment Outcome Denosumab Patient Satisfaction Female Epidemiologic Methods business medicine.drug |
| Zdroj: | Osteoporosis International. 22:1725-1735 |
| ISSN: | 1433-2965 0937-941X |
| Popis: | In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab.The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly.In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (± 1) months apart or 80-100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥ 2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months.The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (p = 0.043) for non-adherence, 0.48 (p = 0.014) for non-compliance, and 0.54 (p = 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (p = 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in10% of subjects in each group).Significantly greater treatment adherence was observed for subcutaneous administration of denosumab every 6 months than for oral alendronate once weekly. |
| Databáze: | OpenAIRE |
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