The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.
There are two major considerations in the use of bisphosphonates in diabetic patients. * The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates. * A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism. The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
150 mg of ibandronate + 24,000 IU of cholecalciferol
Yeouido St.Mary's Hospital
Seoul, South Korea
Bone mineral density
. Percentage change in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck, presented as least square mean and 95% confidence interval.
Time frame: 1 year
Bone turnover markers
Percentage change in bone turnover markers \[Serum C-telopeptide (CTx) and procollagen type 1 N-terminal propeptide (P1NP) levels were measured by immunoassay methods using Elecsys kits - 07296355001V4 and 07296509001V4 (Roche Diagnostic Corp., Basel, Switzerland) \] presented as adjusted mean and 95% confidence interval using the generalized estimating equations for repeated measures analysis.
Time frame: 6 month and 12 month
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