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Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis : results from the 24-week extension of a 15-week randomized, controlled trial
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Binkley, Neil (author)
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Ringe, Johann D. (author)
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Reed, John I. (author)
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- Ljunggren, Östen (author)
- Uppsala universitet,Institutionen för medicinska vetenskaper,Metabolic Bone Disease
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Holick, Michael F. (author)
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Minne, Helmut W. (author)
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Liu, Minzhi (author)
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Lamotta, Amy (author)
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West, Joseph A. (author)
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Santora, Arthur C. (author)
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(creator_code:org_t)
- Elsevier BV, 2009
- 2009
- English.
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In: Bone. - : Elsevier BV. - 8756-3282 .- 1873-2763. ; 44:4, s. 639-647
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- Although vitamin D supplementation is a fundamental part of osteoporosis treatment, many patients do not regularly take adequate amounts. A once-weekly (OW) alendronate (ALN) preparation that includes 2800 IU of vitamin D3 in a single combination tablet (ALN+D2800) is available for treating patients and ensuring intake of vitamin D that is consistent with existing guidelines. This randomized, double-blind study extension was conducted to evaluate the safety and tolerability of ALN+D2800 and ALN+D2800 plus an additional 2800 IU vitamin D3 single tablet supplement (ALN+D5600) administered for 24 weeks in men and postmenopausal women with osteoporosis previously treated OW for 15 weeks with either ALN or ALN+D2800. The primary endpoint was the proportion of participants who developed hypercalciuria (defined as a 24-hour urine calcium >300 mg in women or >350 mg in men and an increase of >25% versus randomization baseline) at week 39. The key secondary endpoint was the proportion of participants with vitamin D insufficiency (serum 25(OH)D <15 ng/mL [37.4 nmol/L]) at the end of the study. Hypercalciuria incidence (4.2% [ALN+D5600] vs. 2.8% [ALN+D2800]), did not differ between groups (p = 0.354). No participants developed hypercalcemia. Among the participants with vitamin D insufficiency at the week 0 baseline, the prevalence of insufficiency at the end of the study was reduced by 92% in the ALN+D5600 group and by 86% in the ALN+D2800 group. The incidences of clinical adverse experiences, including drug-related adverse experiences, were similar in both groups. In subjects previously treated with ALN+D2800 for 15 weeks, the addition of 2800 IU D3 for 24 weeks did not produce hypercalcemia nor increase the risk of hypercalciuria.
Keyword
- MEDICINE
- MEDICIN
Publication and Content Type
- ref (subject category)
- art (subject category)
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Bone
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To the university's database
- By the author/editor
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Binkley, Neil
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Ringe, Johann D.
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Reed, John I.
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Ljunggren, Östen
-
Holick, Michael ...
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Minne, Helmut W.
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show more...
-
Liu, Minzhi
-
Lamotta, Amy
-
West, Joseph A.
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Santora, Arthur ...
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show less...
- Articles in the publication
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Bone
- By the university
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Uppsala University