Comparison of recent IV ibandronate studies
Editor's comments: The table below summarizes several studies of IV ibandronate that were found on PubMed. This is a very potent bisphosphonate that can be given by an IV bolus, unlike previous IV bisphosphonates that had to be given very slowly. If this method is found to be effective at increasing bone mineral density (BMD) and reducing fractures it might be an improvement, especially for individuals that have a hard time with the oral bisphosphonates, since ibandronate can be given in a 2-mg dose every three months. As noted in the 16th Newsletter, individuals who are not responding adequately to oral bisphosphonates might consider discussing the use of an IV bisphosphonate with their physician. Ibandronate is in phase III clinical trials so FDA approval for osteoporosis therapy may be coming soon. Additionally it is approved for other therapies so it could be used as an off-label prescription, although insurance probably wouldn't pay for it.
Note on the table that the 1 mg each 3 months dose was not effective and that there is a range of improvement from a low of 2.5%/year to the high of 5.2% /year for the 2 mg each 3 months dose. These findings appear to be roughly equal to what one would expect when taking oral bisphosphonates. The one finding that is lacking is fracture reduction efficacy, which should be forthcoming as phase III clinical trial results are published.
|
Study |
Participants |
Dose |
Duration |
Spine |
Hip |
Biochem Markers |
Notes |
|
PMID:9382122 |
125 women |
2 mg q 3 months |
1 year |
5.2% |
2.9% total hip |
|
Well tolerated |
|
PMID:12730532 |
49 men, 55 women |
2 mg q 3 months |
2 year |
11.9% |
4.7% neck |
|
Trend toward fx reduction. 500 mg Ca+. Steroid-induced osteoporosis. |
|
PMID:12830369 |
73 women |
2 mg q 84 days |
168 days |
NA |
NA |
s-CTx nadir in 7 days, Max -90% . s-OC nadir 5 months, -35%. |
Suppression vs. resorption may be problematic |
|
PMID:12972476 |
629 women |
2 mg q 3 months |
1 year |
2.5% |
Not shown |
Suppressed markers of bone turnover |
Well tolerated |
|
PMID:14610641 |
115 men/women |
2 mg q 3 months |
3 year |
13.3% |
5.2% neck |
NA |
500 mg Ca+/day. Placebo gets 1 microg alfacalcidol/day. Steroid-induced osteoporosis |
|
PMID:15121021 |
2862 women |
1 mg q 3months |
3 year |
4% |
NA |
NA |
400 IU vit D, 500 mg Ca+ |
|
PMID:14669826 |
14 men |
2 mg q 3 months |
2 year |
6.7% |
1.4% neck |
s-beta crosslaps and s-OC decreased 30-45 and 30%, respectively. |
Pilot study, 1 gm/d Ca+, 880 IU vit D |