Osteoporosis, Postmenopausal, Type 2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIbandronate Oral Tablet
150 mg of ibandronate + 24,000 IU of cholecalciferol
Sponsors
Samsung Medical Center
Seoul National University Bundang Hospital
Yeouido St. Mary's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age of at least 55 years at the time of screening * postmenopausal woman * diagnosis of osteoporosis
Exclusion criteria
* history of osteoporosis treatment * underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy) * the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants) * history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone turnover markers | 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. |
Countries
South Korea
Outcome results
None listed