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Completed

NCT Number: NCT05266261

Use of Ibandronate in Diabetic Patients

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.

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Key information

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yeouido St.Mary's Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibandronate Oral Tablet

Drug

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

Primary outcomes

  1. Bone mineral density

    Time frame: 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 outcomes

  1. Bone turnover markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yeouido St. Mary's Hospital

Other

Collaborators

  • Samsung Medical Center
  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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