Timing of food intake has a marked effect on the bioavailability of clodronate

Laitinen, Kalevi; Patronen, A; Harju, P; Löyttyniemi, Eliisa; Pylkkänen, Liisa; Kleimola, Terttu; Perttunen, K

doi:10.1016/s8756-3282(00)00321-5

Cited by 31 publications

(6 citation statements)

References 14 publications

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“…In a study of alendronate, ingestion of breakfast within 30–60 min reduced the bioavailability by 40%, concomitant ingestion with coffee or orange juice caused a 60% decrease, and concomitant ingestion of food and coffee almost completely abolished absorption. Similar studies with other bisphosphonates have mirrored these data [23].…”

Section: Introductionsupporting

confidence: 83%

How Much Calcium is in your Drinking Water? A Survey of Calcium Concentrations in Bottled and Tap Water and Their Significance for Medical Treatment and Drug Administration

Morr

Cuartas

Alwattar

et al. 2006

HSS Journal®: The Musculoskeletal Journal of Hospital for Speci

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Calcium concentration in water varied substantially from different sources in the USA and Canada. Bottled waters presented with concentrations of calcium covering a very large range. Certain tap and bottled waters present with concentrations of calcium sufficient to exhibit a deleterious effect on bisphosphonate treatment. Alternatively, certain waters may be used as a source of calcium that may provide over 40% of the recommended daily intake for calcium.

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Section: Introductionsupporting

confidence: 83%

How Much Calcium is in your Drinking Water? A Survey of Calcium Concentrations in Bottled and Tap Water and Their Significance for Medical Treatment and Drug Administration

Morr

Cuartas

Alwattar

et al. 2006

HSS Journal®: The Musculoskeletal Journal of Hospital for Speci

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“…This recommendation was based on recent pharmacologic data with other bisphosphonates [16]. Indeed, later pharmacologic data have shown that when taken 2 h after a meal, the absorption of clodronate was only 34% of the optimum achieved when the drug was taken 0.5-2 h before a meal [17]. Consequently when comparing the BMD changes in the primary versus the extension study, the BMD-increasing effect of 800 mg of clodronate in the lumbar spine and the trochanter was larger, and bone loss was smaller, in the femoral neck.…”

Section: Discussionmentioning

confidence: 99%

Prevention of Bone Loss by Clodronate in Early Postmenopausal Women with Vertebral Osteopenia: A Dose-Finding Study

Välimäki

Laitinen

Patronen³

et al. 2002

Osteoporosis International

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This double-masked, placebo-controlled study was undertaken to determine the efficacy and safety of oral clodronate in the prevention of bone loss in early postmenopausal women with vertebral osteopenia. Altogether 610 women with a mean age of 53 years were recruited for the study. They were 1-5 years postmenopausal and their lumbar spine bone mineral density (BMD) was at least 1 standard deviation below the mean of premenopausal women ( T-score < or =-1). The subjects were randomized into five study groups to receive either placebo, clodronate 65 mg, 400 mg or 800 mg daily, or intermittent clodronate in 3 month cycles with 400 mg daily for 15 days followed with no treatment for 75 days for 3 years. One hundred and eighty-seven of 509 women who completed the primary study continued in the extension study of 2 years in which previous placebo users were switched to clodronate 800 mg daily, while previous users of 400 mg or 800 mg of clodronate used either placebo or 800 mg of clodronate daily. In the primary study clodronate was administered in the evening, and in the extension 1 h before breakfast on an empty stomach. In the primary study mean changes in lumbar spine BMD were -3.4% in the placebo group and +0.4% in 800 mg clodronate group [difference between groups at 3 years 3.8% (95% CI 2.7% to 4.9%, p<0.0001)], and in the trochanter area BMD -1.1% in the placebo group, and + 0.4% in the 800 mg clodronate group [difference between groups at 3 years 1.5% (95% CI 0.05% to 2.9%)]. During the extension study mean changes in lumbar spine BMD were +1.5% in the clodronate group and -0.2 % in the placebo group [difference between groups 1.7% (CI 0.4% to 3.0%, p = 0.010)] and in trochanter BMD were +2.5% in the clodronate group and no change in the placebo group [difference between groups 2.1% (CI 0.3% to 3.9%, p = 0.007)]. No statistically significant differences between the placebo and 800 mg clodronate groups were found in the femoral neck BMD. In the primary study the urinary excretion of type I collagen aminoterminal telopeptide (NTX) decreased by 44% ( p<0.0001 compared with placebo) and that of deoxypyridinoline by 18% ( p<0.0001) in the clodronate 800 mg group. In the extension study urinary NTX decreased by 51% ( p<0.0001) in those who were switched to 800 mg of clodronate and increased by 67% ( p<0.0001) in those who stopped using that dose. There was no difference in the frequency of gastrointestinal complaints between clodronate- and placebo-treated patients in the primary study, but they were more common among women who received clodronate in the extension phase. Clodronate in daily doses of 400-800 mg caused a slight elevation of aminotransferase levels, usually within the reference range. In bone biopsies no defect in mineralization was found. In conclusion, clodronate in a daily dose of 800 mg prevents early postmenopausal bone loss at the sites of the skeleton in which cancellous bone predominates. It effectively reduces bone resorption and bone turnover rate. Antifracture efficacy of clodronate remains ...

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“…We have successfully developed pharmaceutical technology that allows negative food effects to be completely circumvented. Numerous studies on food–drug interactions have been reported (http://www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf; http://www.merck.com/product/usa/pi_circulars/s/syprine/syprine_pi.pdf),4–18 but only a few have described technologies that can reduce negative food effects 40, 41. When pharmaceutical manufactures recognize that a drug candidate shows negative food effects in humans, the practical alternatives are either to find a manner to ensure strict compliance with the dosing instructions, or to discontinue the development.…”

Section: Resultsmentioning

confidence: 99%

“…Drug absorption via the gastrointestinal (GI) tract is affected by the timing of drug administration in relation to meals 1–3. Often, drug absorption is increased when patients take a drug after a meal (positive food effect), but in other cases, drugs show poor absorption when they are administered after a meal (negative food effect) 4–16. The most important concern regarding food–drug interactions is the high risk of treatment failure in patients who take a drug with a negative food effect after a meal 1…”

Section: Introductionmentioning

confidence: 99%

Site-specific drug delivery to the middle-to-lower region of the small intestine reduces food–drug interactions that are responsible for low drug absorption in the fed state

Tanno

Sakuma

Masaoka

et al. 2008

Journal of Pharmaceutical Sciences

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Timing of food intake has a marked effect on the bioavailability of clodronate

Cited by 31 publications

References 14 publications

How Much Calcium is in your Drinking Water? A Survey of Calcium Concentrations in Bottled and Tap Water and Their Significance for Medical Treatment and Drug Administration

How Much Calcium is in your Drinking Water? A Survey of Calcium Concentrations in Bottled and Tap Water and Their Significance for Medical Treatment and Drug Administration

Prevention of Bone Loss by Clodronate in Early Postmenopausal Women with Vertebral Osteopenia: A Dose-Finding Study

Site-specific drug delivery to the middle-to-lower region of the small intestine reduces food–drug interactions that are responsible for low drug absorption in the fed state

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