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Use of Ibandronate in Diabetic Patients

Sponsor
Yeouido St. Mary's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05266261
Collaborator
Samsung Medical Center (Other), Seoul National University Bundang Hospital (Other)
121
Enrollment
1
Location
2
Arms
40
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ibandronate Oral Tablet
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yeouido St.Mary's Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yeouido St. Mary's Hospital
    • Samsung Medical Center
    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Ki-Hyun Baek, M.D., Ph.D., Yeouido St. Mary's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yeouido St. Mary's Hospital
    ClinicalTrials.gov Identifier:
    NCT05266261
    Other Study ID Numbers:
    • SC18MEDV0024
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Cholecalciferol
    Ibandronic Acid
    Calcium Carbonate

    Study Results

    No Results Posted as of Mar 4, 2022