Abstract | OBJECTIVE: METHODS: This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; > or = 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and > or = -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 I 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:
|
Authors | John A Eisman, Roberto Civitelli, Silvano Adami, Edward Czerwinski, Chris Recknor, Richard Prince, Jean-Yves Reginster, Mone Zaidi, Dieter Felsenberg, Claire Hughes, Nicole Mairon, Daiva Masanauskaite, David M Reid, Pierre D Delmas, Robert R Recker |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 35
Issue 3
Pg. 488-97
(Mar 2008)
ISSN: 0315-162X [Print] Canada |
PMID | 18260172
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Bone Density Conservation Agents
- Diphosphonates
- Ibandronic Acid
|
Topics |
- Administration, Oral
- Aged
- Bone Density
(drug effects)
- Bone Density Conservation Agents
(administration & dosage, adverse effects)
- Diphosphonates
(administration & dosage, adverse effects)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Humans
- Ibandronic Acid
- Infusions, Intravenous
- Lumbar Vertebrae
(drug effects)
- Middle Aged
- Osteoporosis, Postmenopausal
(drug therapy)
|