Use of Ibandronate in Diabetic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Ibandronate Oral Tablet

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yeouido St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yeouido St. Mary's Hospital
• Collaborators: Samsung Medical Center; Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Ki-Hyun Baek, M.D., Ph.D., Yeouido St. Mary's Hospital

Publications and helpful links

General Publications

• Kim J, Kim KM, Lim S, Kang MI, Baek KH, Min YK. Efficacy of bisphosphonate therapy on postmenopausal osteoporotic women with and without diabetes: a prospective trial. BMC Endocr Disord. 2022 Apr 11;22(1):99. doi: 10.1186/s12902-022-01010-w.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Cholecalciferol; Calcium Carbonate; Ibandronic Acid
• Other Study ID Numbers: SC18MEDV0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No