Use of Ibandronate in Diabetic Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Osteoporosis, Postmenopausal
• Interventions: Drug: Ibandronate Oral Tablet

• Registration Number: NCT05266261
• Lead Sponsor: Yeouido St. Mary's Hospital

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2021-08-30
• Study Completion: 2022-01-31
• Status Verified: 2022-02
• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-diabetes	Ibandronate Oral Tablet	postmenopausal women with normal glucose tolerance
diabetes	Ibandronate Oral Tablet	postmenopausal women with type 2 diabetes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Yeouido St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of