Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
Overview
- Phase
- Not Applicable
- Intervention
- Ibandronate Oral Tablet
- Conditions
- Osteoporosis, Postmenopausal
- Sponsor
- Yeouido St. Mary's Hospital
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Bone mineral density
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Non-diabetes
postmenopausal women with normal glucose tolerance
Intervention: Ibandronate Oral Tablet
diabetes
postmenopausal women with type 2 diabetes
Intervention: Ibandronate Oral Tablet
Outcomes
Primary Outcomes
Bone mineral density
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.
Secondary Outcomes
- Bone turnover markers(6 month and 12 month)