Use of Ibandronate in Diabetic Patients

Yeouido St. Mary's Hospital

Status

Completed

Conditions

Type 2 Diabetes

Osteoporosis, Postmenopausal

Treatments

Drug: Ibandronate Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05266261

SC18MEDV0024

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

Female

Ages

55+ years old

Volunteers

No Healthy Volunteers

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