Use of Ibandronate in Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial

Conditions
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Osteoporosis, Postmenopausal, Type 2 Diabetes

Intervention / Treatment
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* Drug: Ibandronate Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-diabetes<br>postmenopausal women with normal glucose tolerance | Drug: Ibandronate Oral Tablet<br>* 150 mg of ibandronate + 24,000 IU of cholecalciferol<br>* Other names: daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol;|
| Experimental: diabetes<br>postmenopausal women with type 2 diabetes | Drug: Ibandronate Oral Tablet<br>* 150 mg of ibandronate + 24,000 IU of cholecalciferol<br>* Other names: daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 month and 12 month |