RESEARCH - IV Boniva (ibandronate) injections in postmenopausal women with osteoporosis

[Guest guest]

Arthritis Rheum. 2006 May 25;54(6):1838-1846 [Epub ahead of print]

Intravenous ibandronate injections in postmenopausal women with

osteoporosis: One-year results from the dosing intravenous administration

study.

Delmas PD, Adami S, Strugala C, Stakkestad JA, Reginster JY, Felsenberg D,

Christiansen C, Civitelli R, Drezner MK, Recker RR, Bolognese M, C,

Masanauskaite D, Ward P, Sambrook P, Reid DM.

Universite Claude Bernard Lyon 1 and INSERM Research Unit 403, Lyon, France.

OBJECTIVE: Although oral bisphosphonates are effective treatments for

postmenopausal women with osteoporosis, oral dosing may be unsuitable for

some patients. An efficacious intravenously administered bisphosphonate

could be beneficial for such patients. Ibandronate, a potent

nitrogen-containing bisphosphonate, can be administered using extended

dosing intervals, either orally or by rapid intravenous injection. The aim

of this study was to identify the optimal intravenous dosing regimen for

ibandronate in postmenopausal women with osteoporosis. METHODS: In a

randomized, double-blind, double-dummy, phase III, noninferiority study, we

compared 2 regimens of intermittent intravenous injections of ibandronate (2

mg every 2 months and 3 mg every 3 months) with a regimen of 2.5 mg of oral

ibandronate daily, the latter of which has proven antifracture efficacy. The

study group comprised 1,395 women (ages 55-80 years) who were at least 5

years postmenopausal. All patients had osteoporosis (lumbar spine [L2-L4]

bone mineral density [bMD] T score less than -2.5). Participants also

received daily calcium (500 mg) and vitamin D (400 IU). The primary end

point was change from baseline in lumbar spine BMD at 1 year. Changes in hip

BMD and in the level of serum C-telopeptide of type I collagen (CTX) were

also measured, as were safety and tolerability. RESULTS: At 1 year, mean

lumbar spine BMD increases were as follows: 5.1% among 353 patients

receiving 2 mg of ibandronate every 2 months, 4.8% among 365 patients

receiving 3 mg of ibandronate every 3 months, and 3.8% among 377 patients

receiving 2.5 mg of oral ibandronate daily. Both of the intravenous regimens

not only were noninferior, but also were superior (P < 0.001) to the oral

regimen. Hip BMD increases (at all sites) were also greater in the groups

receiving medication intravenously than in the group receiving ibandronate

orally. Robust decreases in the serum CTX level were observed in all arms of

the study. Both of the intravenous regimens were well tolerated and did not

compromise renal function.

CONCLUSION: As assessed by BMD, intravenous injections of ibandronate (2 mg

every 2 months or 3 mg every 3 months) are at least as effective as the

regimen of 2.5 mg orally daily, which has proven antifracture efficacy, and

are well tolerated.

PMID: 16729277

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=16729277

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

,

Thank you, you ALWAYS come through for everyone, especially me. I am

not sure what to do about taking it. I am always afraid of taking a new

drug. I guess I have to weigh losing two inches at this point and trying to

stop the destruction of the bones and giving this drug a chance.

Thank you again my friend, you are so special.

Lynn

[ ] RESEARCH - IV Boniva (ibandronate) injections in

postmenopausal women with osteoporosis

> Arthritis Rheum. 2006 May 25;54(6):1838-1846 [Epub ahead of print]

>

>

> Intravenous ibandronate injections in postmenopausal women with

> osteoporosis: One-year results from the dosing intravenous administration

> study.

>

>

> Delmas PD, Adami S, Strugala C, Stakkestad JA, Reginster JY, Felsenberg D,

> Christiansen C, Civitelli R, Drezner MK, Recker RR, Bolognese M, C,

> Masanauskaite D, Ward P, Sambrook P, Reid DM.

>

> Universite Claude Bernard Lyon 1 and INSERM Research Unit 403, Lyon,

> France.

>

> OBJECTIVE: Although oral bisphosphonates are effective treatments for

> postmenopausal women with osteoporosis, oral dosing may be unsuitable for

> some patients. An efficacious intravenously administered bisphosphonate

> could be beneficial for such patients. Ibandronate, a potent

> nitrogen-containing bisphosphonate, can be administered using extended

> dosing intervals, either orally or by rapid intravenous injection. The aim

> of this study was to identify the optimal intravenous dosing regimen for

> ibandronate in postmenopausal women with osteoporosis. METHODS: In a

> randomized, double-blind, double-dummy, phase III, noninferiority study,

> we

> compared 2 regimens of intermittent intravenous injections of ibandronate

> (2

> mg every 2 months and 3 mg every 3 months) with a regimen of 2.5 mg of

> oral

> ibandronate daily, the latter of which has proven antifracture efficacy.

> The

> study group comprised 1,395 women (ages 55-80 years) who were at least 5

> years postmenopausal. All patients had osteoporosis (lumbar spine [L2-L4]

> bone mineral density [bMD] T score less than -2.5). Participants also

> received daily calcium (500 mg) and vitamin D (400 IU). The primary end

> point was change from baseline in lumbar spine BMD at 1 year. Changes in

> hip

> BMD and in the level of serum C-telopeptide of type I collagen (CTX) were

> also measured, as were safety and tolerability. RESULTS: At 1 year, mean

> lumbar spine BMD increases were as follows: 5.1% among 353 patients

> receiving 2 mg of ibandronate every 2 months, 4.8% among 365 patients

> receiving 3 mg of ibandronate every 3 months, and 3.8% among 377 patients

> receiving 2.5 mg of oral ibandronate daily. Both of the intravenous

> regimens

> not only were noninferior, but also were superior (P < 0.001) to the oral

> regimen. Hip BMD increases (at all sites) were also greater in the groups

> receiving medication intravenously than in the group receiving ibandronate

> orally. Robust decreases in the serum CTX level were observed in all arms

> of

> the study. Both of the intravenous regimens were well tolerated and did

> not

> compromise renal function.

>

> CONCLUSION: As assessed by BMD, intravenous injections of ibandronate (2

> mg

> every 2 months or 3 mg every 3 months) are at least as effective as the

> regimen of 2.5 mg orally daily, which has proven antifracture efficacy,

> and

> are well tolerated.

>

> PMID: 16729277

>

>

>

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=16729277

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

>

>

>