Intravenous ibandronate (Boniva) – April 2007
Arthritis Rheum. 2006 Jun;54(6):1838-46. Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study, Delmas, PD and others. PMID: 16729277. This study showed that either of two dosing regimens ( 2 mg every 2 months or 3 mg every 3 months) for intravenous (IV) ibandronate (Boniva) were superior (P < 0.001) to oral ibandronate (2.5 mg/day). Although spine bone mineral density (BMD) was the main measurement point where superiority was detected, it was also noted that hip BMD increases at all sites were also greater in the IV groups than in the oral medication groups. Fracture decrease was not a part of this study other than the notation that oral ibandronate has been shown to decrease fracture risk, so there would be an assumption the same fracture reduction could be expected from the IV medication. However, future studies will have to show this conclusively. Significant notes from the full article. The authors note that IV medications may be needed for those patients with gastrointestinal intolerance to oral medications, esophageal abnormalities, and for those with inability to comply with the special procedures required for bisphosphonates, such as long wait times after ingestion, sitting or standing upright, etc. The key feature setting IV ibandronate apart from other IV bisphosphonates—aside from its high potency—is that it can be given in a rapid (15-30 second) injection with extended dose-free intervals. Responder rates (BMD was equal to or greater than the starting BMD at the measure point) were better for both IV dosing regimens than for the oral one. For the spine, 92.6% and 92.1% rates were found for the every-2-month and every-3-month groups, respectively. This compared to 84.9% for the oral group. Similar but lower responder rates were found in the hip. Tolerability (adverse events) were similar across all three treatment groups with no reports of jaw osteonecrosis. There was a higher incidence of flu-like symptoms in the IV groups compared to the oral group. Editor's comments. FDA Approval and insurance issues. IV ibandronate was approved by the FDA in January 2006 as a 3 mg every-3-month medication. It must be given in the medical setting, so it will be a medical procedure that should fall under your medical insurance if you want to compare the cost versus oral medications. Obviously you would want to find out if your insurer approves the IV therapy before starting that method. Responder rate. The responder rate is a very important issue in my thinking. We always deal with mean (the average of all) responses in clinical trials. The average response can be very deceptive since some might not respond at all while others respond double what the average result is. It is significant that there is about a 92% response rate for spine BMD in the IV study participants. One of the reasons that someone might want to try the IV method is that they have found, after a year or more on oral medications, that their BMD is not improving. This could possibly be due to some malabsorption problem that would be completely circumvented by the IV route. Thus I suggest that men who are not responding to oral bisphosphonates discus the IV ibandronate treatment option with their care provider. I receive a few emails from men every year who are in this category, so this gives them another medication than what we've had previously. Jaw osteonecrosis. If you've followed the information on this site regarding jaw osteonecrosis, you are fully aware that the IV bisphosphonates are the ones commonly associated with jaw osteonecrosis. Note, however, that it is when these IV bisphosphonates are given in high doses for cancer treatment that jaw osteonecrosis occurs most commonly. To see the difference in dosages, see Anticancer Research 26:3133-3136 (2006), Rapid infusion of ibandronate in lung cancer patients with bone metastases. Kiagia M and others. PMID: 16886646. When treating the lung cancer metastases in this study, patients were given a total of 189 infusions over a 24-month period. These had 4 mg IV ibandronate every 3-4 weeks or more than 12 mg every 3 months. This is over four times the ibandronate dosage given to treat osteoporosis, so there would appear to be a considerable margin of error in favor of those receiving therapy for osteoporosis with IV ibandronate. I searched PubMed for reported cases of jaw osteonecrosis with ibandronate and nothing comes up. A Google search shows ibandronate listed with other bisphosphonates most times, however, I did find one case report for oral ibandronate mentioned here. There is no guarantee that low-dose IV ibandronate will assure low rates of jaw osteonecrosis, but logically one would think that might be the case. Each person has to weigh the risks and rewards for taking each type of medication for osteoporosis and choose the best one for your needs after consulting with your care provider.