Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2011-10-06

AUTHORS

G. Bianchi, E. Czerwinski, A. Kenwright, A. Burdeska, R. R. Recker, D. Felsenberg

ABSTRACT

Long-term bone mineral density (BMD) gains, bone marker levels, and safety of 3 mg quarterly intravenous (IV) ibandronate were studied in this 3-year extension to the Dosing IntraVenous Administration (DIVA) trial. Quarterly IV ibandronate consistently increased lumbar spine bone mineral density measured with dual-energy X-ray absorptiometry (DXA-BMD) over 5 years (8.1%) and was well tolerated in women with postmenopausal osteoporosis.IntroductionTreatment with IV ibandronate regimens, 2 mg bimonthly and 3 mg quarterly, has been studied for up to 5 years in a long-term extension (LTE) to the 2-year DIVA trial.MethodsDIVA LTE is an open-label extension to a 2-year randomized, double-blind, double-dummy, noninferiority, phase III study (DIVA core). DIVA LTE involved postmenopausal women who had completed 2 years of DIVA core, comparing daily oral and IV ibandronate (≥75% adherence with IV ibandronate in year 2 of DIVA). Patients previously treated with 2 mg bimonthly or 3 mg quarterly IV ibandronate continued on the same regimen; patients who had received 2.5 mg daily oral ibandronate and placebo IV in DIVA core were switched to IV ibandronate.ResultsPooled analysis of 497 intent-to-treat (ITT) patients receiving IV ibandronate from DIVA core baseline showed consistent increases over 5 years in lumbar spine DXA-BMD (8.4% [95% confidence interval (CI) = 7.5, 9.3] with 2 mg bimonthly and 8.1% [95% CI = 7.2, 8.9] with 3 mg quarterly). Three-year data relative to DIVA LTE baseline in the full ITT population (756 patients randomized or reallocated from DIVA, including those previously on daily treatment) showed maintenance of DXA-BMD gains from DIVA core with further gains in lumbar spine DXA-BMD. These benefits are supported by sustained reductions in markers of bone metabolism. No tolerability concerns or new safety signals were observed.ConclusionsTreatment with IV ibandronate 2 mg bimonthly or 3 mg quarterly is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis. More... »

PAGES

1769-1778

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00198-011-1793-9

DOI

http://dx.doi.org/10.1007/s00198-011-1793-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1038256783

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21975558


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45 IntroductionTreatment
46 X-ray absorptiometry
47 absorptiometry
48 administration
49 administration trial
50 analysis
51 baseline
52 benefits
53 bone marker levels
54 bone metabolism
55 bone mineral density
56 bone mineral density gains
57 concern
58 consistent increase
59 core
60 core baseline
61 daily oral ibandronate
62 data
63 density
64 density gain
65 dive trials
66 dual-energy X-ray absorptiometry
67 extension
68 full ITT population
69 further gains
70 gain
71 ibandronate
72 ibandronate regimens
73 increase
74 intent
75 intravenous ibandronate
76 levels
77 long-term administration
78 long-term extension
79 lumbar spine bone mineral density
80 maintenance
81 marker levels
82 markers
83 metabolism
84 mineral density
85 new safety signals
86 noninferiority
87 open-label extension
88 oral ibandronate
89 osteoporosis
90 patients
91 placebo IV
92 population
93 postmenopausal osteoporosis
94 postmenopausal women
95 quarterly intravenous ibandronate
96 reduction
97 regimen
98 regimens
99 safety
100 safety signals
101 same regimen
102 signals
103 spine bone mineral density
104 study
105 sustained reduction
106 three-year data
107 tolerability concerns
108 treat patients
109 trials
110 women
111 years
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