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Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss.
Bone. 2009 Mar; 44(3):418-22.BONE

Abstract

INTRODUCTION

Monthly oral ibandronate has been shown to increase bone mineral density (BMD) and reduce bone turnover in postmenopausal women with osteoporosis, but its efficacy has not been investigated in women with low bone mass. The objective of this study was to examine the efficacy and safety of monthly oral ibandronate (150 mg) treatment in postmenopausal women with low bone mass.

METHODS

This 1-year, double-blind, placebo-controlled, randomized study enrolled ambulatory postmenopausal women aged 45-60 years with baseline lumbar spine (LS) BMD T-score<-1.0 and >-2.5 and baseline T-score>-2.5 at the total hip, trochanter, and femoral neck (collectively defined as the proximal femur) and no prior vertebral or low-trauma osteoporotic fractures at baseline. Subjects received either 150 mg monthly oral ibandronate or placebo. All subjects received calcium and vitamin D supplements. The primary endpoint was the relative change from baseline (%) in mean LS BMD at 1 year (intent-to-treat population). Treatment groups were compared by means of a two-way ANOVA model which adjusted for independent factors including treatment group, baseline LS BMD T-score, and time since menopause. Responder analyses examined the percentage of participants with changes from baseline in LS BMD and proximal femur BMD>or=0%. Adverse events and safety laboratory parameters were monitored continuously.

RESULTS

A total of 77 women received monthly ibandronate and 83 women received placebo. Subjects treated with ibandronate achieved larger increases in LS BMD after 1 year compared with subjects receiving placebo (3.7% vs -0.4% [difference of 4.1%, p<0.0001]). After 3 months, median serum C-terminal telopeptide of type I collagen levels were reduced by >55% in the ibandronate group compared with approximately 4% in the placebo group. At 1 year, 88.2% of the participants treated with ibandronate achieved increases in LS BMD>or=0% compared with 38.6% of subjects receiving placebo. Treatment regimens were well tolerated in both the ibandronate-treated and placebo groups.

CONCLUSION

Monthly ibandronate therapy prevents bone loss in postmenopausal women with low bone mass.

Authors+Show Affiliations

Oregon Osteoporosis Center, Portland, OR 97213, USA. mmcclung@orost.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18950736

Citation

McClung, Michael R., et al. "Efficacy and Safety of Monthly Oral Ibandronate in the Prevention of Postmenopausal Bone Loss." Bone, vol. 44, no. 3, 2009, pp. 418-22.
McClung MR, Bolognese MA, Sedarati F, et al. Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. Bone. 2009;44(3):418-22.
McClung, M. R., Bolognese, M. A., Sedarati, F., Recker, R. R., & Miller, P. D. (2009). Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. Bone, 44(3), 418-22. https://doi.org/10.1016/j.bone.2008.09.011
McClung MR, et al. Efficacy and Safety of Monthly Oral Ibandronate in the Prevention of Postmenopausal Bone Loss. Bone. 2009;44(3):418-22. PubMed PMID: 18950736.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. AU - McClung,Michael R, AU - Bolognese,Michael A, AU - Sedarati,Farhad, AU - Recker,Robert R, AU - Miller,Paul D, Y1 - 2008/10/07/ PY - 2008/05/23/received PY - 2008/08/29/revised PY - 2008/09/16/accepted PY - 2008/10/28/pubmed PY - 2009/4/7/medline PY - 2008/10/28/entrez SP - 418 EP - 22 JF - Bone JO - Bone VL - 44 IS - 3 N2 - INTRODUCTION: Monthly oral ibandronate has been shown to increase bone mineral density (BMD) and reduce bone turnover in postmenopausal women with osteoporosis, but its efficacy has not been investigated in women with low bone mass. The objective of this study was to examine the efficacy and safety of monthly oral ibandronate (150 mg) treatment in postmenopausal women with low bone mass. METHODS: This 1-year, double-blind, placebo-controlled, randomized study enrolled ambulatory postmenopausal women aged 45-60 years with baseline lumbar spine (LS) BMD T-score<-1.0 and >-2.5 and baseline T-score>-2.5 at the total hip, trochanter, and femoral neck (collectively defined as the proximal femur) and no prior vertebral or low-trauma osteoporotic fractures at baseline. Subjects received either 150 mg monthly oral ibandronate or placebo. All subjects received calcium and vitamin D supplements. The primary endpoint was the relative change from baseline (%) in mean LS BMD at 1 year (intent-to-treat population). Treatment groups were compared by means of a two-way ANOVA model which adjusted for independent factors including treatment group, baseline LS BMD T-score, and time since menopause. Responder analyses examined the percentage of participants with changes from baseline in LS BMD and proximal femur BMD>or=0%. Adverse events and safety laboratory parameters were monitored continuously. RESULTS: A total of 77 women received monthly ibandronate and 83 women received placebo. Subjects treated with ibandronate achieved larger increases in LS BMD after 1 year compared with subjects receiving placebo (3.7% vs -0.4% [difference of 4.1%, p<0.0001]). After 3 months, median serum C-terminal telopeptide of type I collagen levels were reduced by >55% in the ibandronate group compared with approximately 4% in the placebo group. At 1 year, 88.2% of the participants treated with ibandronate achieved increases in LS BMD>or=0% compared with 38.6% of subjects receiving placebo. Treatment regimens were well tolerated in both the ibandronate-treated and placebo groups. CONCLUSION: Monthly ibandronate therapy prevents bone loss in postmenopausal women with low bone mass. SN - 1873-2763 UR - https://www.unboundmedicine.com/medline/citation/18950736/Efficacy_and_safety_of_monthly_oral_ibandronate_in_the_prevention_of_postmenopausal_bone_loss_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S8756-3282(08)00787-4 DB - PRIME DP - Unbound Medicine ER -