Infusion of ibandronate once every 3 months effectively decreases bone resorption markers and increases bone mineral density in Chinese postmenopausal osteoporotic women: a 1-year study.
The efficacy and safety of intravenous ibandronate were evaluated in postmenopausal osteoporosis women in China. In this multicenter, positive drug-controlled study, 158 postmenopausal osteoporotic women were randomized to receive 2 mg ibandronate given intravenously once every 3 months or 70 mg alendronate given orally once per week. All women also received supplemental calcium (500 mg) and vitamin D (200 IU) daily. One hundred fifty-one patients completed the 1-year study. Ibandronate produced mean increases in bone mineral density (BMD) by 4.27% at the lumbar spine, 3.48% at the femoral neck, and 2.03% at the trochanter. Mean increases in BMD by 4.24% at the lumbar spine, 2.72% at the femoral neck, and 2.99% at the trochanter were observed in the alendronate group. No significant difference was found between the two groups in BMD in all sites measured. Significant decreases in serum c-telopeptide of type I collagen (CTX) and alkaline phosphatase (ALP) were found in the two groups after 1 and 3 months of treatment, respectively; these serum CTX and ALP levels were then maintained at the decreased levels throughout the study period (12 months). No changes of stature were found in the patients of the two groups. Adverse events were similar in the two groups, except more mild muscle pain was observed in the first month after infusion of ibandronate than with oral alendronate (P < 0.001). The results observed in Chinese patients may support the observation that intravenous ibandronate significantly reduced bone resorption and increased BMD with good tolerance in Chinese postmenopausal osteoporotic women. Use of intravenous ibandronate possibly could potentially improve compliance as compared with other oral bisphosphonates because it may avoid the peptic side effects of oral bisphosphonate.
Department of Endocrinology, Endocrine Key Laboratory of the Health Ministry of China, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. limeilzh@yahoo.com
Mei
M
Li
Xiao-ping
XP
Xing
Zhen-lin
ZL
Zhang
Jian-li
JL
Liu
Zhong-lan
ZL
Zhang
Dong-gang
DG
Liu
Wei-bo
WB
Xia
Xun-wu
XW
Meng
D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001827:Body Height; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001862:Bone Resorption / Q000097:blood*; D002681:China; D024042:Collagen Type I / Q000097:blood; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005269:Femur / Q000737:chemistry; D005272:Femur Neck / Q000737:chemistry; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D008159:Lumbar Vertebrae / Q000737:chemistry; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy*; D010146:Pain / Q000139:chemically induced; D010455:Peptides / Q000097:blood; D013997:Time Factors
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004164:Diphosphonates; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000469:Alkaline Phosphatase; D000077557:Ibandronic Acid