Back to resultsUse of Ibandronate in Diabetic Patients
Primary Purpose
Osteoporosis, Postmenopausal, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ibandronate Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility Criteria
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
Sites / Locations
- Yeouido St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Non-diabetes
diabetes
Arm Description
postmenopausal women with normal glucose tolerance
postmenopausal women with type 2 diabetes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05266261
First Posted
February 20, 2022
Last Updated
March 2, 2022
Sponsor
Yeouido St. Mary's Hospital
Collaborators
Samsung Medical Center, Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05266261
Brief Title
Use of Ibandronate in Diabetic Patients
Official Title
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeouido St. Mary's Hospital
Collaborators
Samsung Medical Center, Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-diabetes
Arm Type
Active Comparator
Arm Description
postmenopausal women with normal glucose tolerance
Arm Title
diabetes
Arm Type
Experimental
Arm Description
postmenopausal women with type 2 diabetes
Intervention Type
Drug
Intervention Name(s)
Ibandronate Oral Tablet
Other Intervention Name(s)
daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol
Intervention Description
150 mg of ibandronate + 24,000 IU of cholecalciferol
Primary Outcome Measure Information:
Title
Bone mineral density
Description
. 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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone turnover markers
Description
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.
Time Frame
6 month and 12 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Hyun Baek, M.D., Ph.D.
Organizational Affiliation
Yeouido St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeouido St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Citations:
PubMed Identifier
35410197
Citation
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.
Results Reference
derived
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Use of Ibandronate in Diabetic Patients
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