TY - JOUR
T1 - Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis
T2 - 2-Year results from the DIVA study
AU - Eisman, John A.
AU - Civitelli, Roberto
AU - Adami, Silvano
AU - Czerwinski, Edward
AU - Recknor, Chris
AU - Prince, Richard
AU - Reginster, Jean Yves
AU - Zaidi, Mone
AU - Felsenberg, Dieter
AU - Hughes, Claire
AU - Mairon, Nicole
AU - Masanauskaite, Daiva
AU - Reid, David M.
AU - Delmas, Pierre D.
AU - Recker, Robert R.
PY - 2008/3
Y1 - 2008/3
N2 - Objective. An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing Intra Venous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen. We report the effects on lumbar spine and proximal femur bone mineral density (BMD) and bone resorption markers over 2 years. Methods. This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; ≥ 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and ≥ -5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study. Results. At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4% and 6.3% vs 4.8%, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type 1 collagen were reduced to a similar extent in all treatment arms (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.
AB - Objective. An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing Intra Venous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen. We report the effects on lumbar spine and proximal femur bone mineral density (BMD) and bone resorption markers over 2 years. Methods. This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; ≥ 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and ≥ -5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study. Results. At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4% and 6.3% vs 4.8%, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type 1 collagen were reduced to a similar extent in all treatment arms (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.
KW - Bisphosphonate
KW - Ibandronate
KW - Intravenous
KW - POStmenopausal osteoporosis
UR - http://www.scopus.com/inward/record.url?scp=40649109120&partnerID=8YFLogxK
M3 - Article
C2 - 18260172
AN - SCOPUS:40649109120
SN - 0315-162X
VL - 35
SP - 488
EP - 497
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 3
ER -