Use of Ibandronate in Diabetic Patients

NCT05266261 | Completed

• 1 other identifier: SC18MEDV0024
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Postmenopausal; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bone turnover markers

  6 month and 12 month

Study Arms (2)

Non-diabetes

ACTIVE COMPARATOR

postmenopausal women with normal glucose tolerance

Drug: Ibandronate Oral Tablet

diabetes

EXPERIMENTAL

postmenopausal women with type 2 diabetes

Drug: Ibandronate Oral Tablet

Interventions

Ibandronate Oral Tablet DRUG

150 mg of ibandronate + 24,000 IU of cholecalciferol

Also known as: daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol

Non-diabetes; diabetes

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of at least 55 years at the time of screening
• postmenopausal woman
• diagnosis of osteoporosis

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Yeouido St.Mary's Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35410197 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Diabetes Mellitus, Type 2

Interventions

Ibandronic Acid; Calcium Carbonate; Cholecalciferol

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Ki-Hyun Baek, M.D., Ph.D.

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 4, 2022
• Study Start: October 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: January 31, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)