Yeouido St.Mary's Hospital
Seoul, South Korea
NCT Number: NCT05266261
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.
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Notify Me55 year and older
Female
Interventional
Not applicable
Seoul, South Korea
There are two major considerations in the use of bisphosphonates in diabetic patients.
The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
150 mg of ibandronate + 24,000 IU of cholecalciferol
Other names: daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol
Time frame: 1 year
. 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: 6 month and 12 month
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.
Yeouido St. Mary's Hospital
Other
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
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