Use of Ibandronate in Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266261
• Other study ID #: SC18MEDV0024
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: Yeouido St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 31, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Type 2 Diabetes

Intervention

Drug:
• Ibandronate Oral Tablet
150 mg of ibandronate + 24,000 IU of cholecalciferol

Locations

Country	Name	City	State
Korea, Republic of	Yeouido St.Mary's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Yeouido St. Mary's Hospital	Samsung Medical Center, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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