Treatment with once‐weekly alendronate oral jelly compared with once‐weekly alendronate oral tablet for Japanese patients with primary osteoporosis: An open‐label, prospective, observational study
| Autor: | Takayuki Ogawa, Hidehiro Matsumoto, Yukari Uemura, Akinori Sakai, Ken Hirao, Yuichi Okazaki, Tsuyoshi Nakagawa, Toru Yoshioka, Nobukazu Okimoto, Satoshi Ikeda, Hiroshi Tsurukami, Shinobu Arita, Satoshi Nishida, Yoriko Toten, Hajime Otomo, Yuji Katae |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Bone density Visual analogue scale Osteoporosis 030209 endocrinology & metabolism Context (language use) elderly Bone remodeling 03 medical and health sciences 0302 clinical medicine Endocrinology Internal medicine medicine Research Articles Femoral neck Bone mineral drug administration routes business.industry Heartburn bone density General Medicine alendronate medicine.disease osteoporosis medicine.anatomical_structure Japanese 030101 anatomy & morphology medicine.symptom business Research Article |
| Zdroj: | Health Science Reports |
| ISSN: | 2398-8835 |
| Popis: | Background and aims Clinical data regarding alendronate jelly are limited. We compared the efficacy and safety of once‐weekly alendronate oral jelly with once‐weekly alendronate tablet formulations in the context of primary osteoporosis. Methods In this 6‐month, open‐label, prospective, observational study, Japanese patients aged ≥60 years with primary osteoporosis were included from 14 primary care centres in Japan. The effects of once‐weekly alendronate oral jelly and tablet formulations on bone mineral density (BMD), bone turnover markers, and quality of life related to gastrointestinal symptoms were assessed at baseline and 6 months. Treatment was allocated by patient preference. This potentially confounding factor was adjusted for statistically. Results In total, 170 patients were enrolled (jelly, n = 97; tablet, n = 73). Mean percent changes in radius, lumbar spine, femoral neck, and hip BMD were similar in both treatment groups at 6 months. Both formulations decreased tartrate‐resistant acid phosphatase 5b (TRACP‐5b) and procollagen 1 N‐terminal peptide (P1NP) between baseline and 6 months (by about 50% and 60%, respectively); no significant differences in mean changes were noted in these markers between groups. At 6 months, no significant differences were noted in visual analogue scale or EuroQOL five‐dimension questionnaire scores between groups. The jelly group had significantly lower scores than the tablet group in the Izumo scale domains of heartburn (−0.81, P = 0.0040), epigastralgia (−0.94, P = 0.0003), and epigastric fullness (−0.49, P = 0.044). During treatment, more patients discontinued for upper gastrointestinal symptoms in the tablet group (n = 4) than the jelly group (n = 1). Conclusions Once‐weekly alendronate oral jelly 35 mg may be a suitable alternative therapeutic agent for primary osteoporosis in Japan. |
| Databáze: | OpenAIRE |
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