---
title: Use of Ibandronate in Diabetic Patients
nct_id: NCT05266261
overall_status: COMPLETED
phase: NA
sponsor: "Yeouido St. Mary's Hospital"
study_type: INTERVENTIONAL
primary_condition: Osteoporosis, Postmenopausal
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05266261.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05266261"
ct_last_update_post_date: 2022-03-04
last_seen_at: "2026-05-12T07:03:09.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Use of Ibandronate in Diabetic Patients

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

**NCT ID:** [NCT05266261](https://clinicaltrials.gov/study/NCT05266261)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 121
- **Lead Sponsor:** Yeouido St. Mary's Hospital
- **Collaborators:** Samsung Medical Center, Seoul National University Bundang Hospital
- **Conditions:** Osteoporosis, Postmenopausal, Type 2 Diabetes
- **Start Date:** 2018-10-01
- **Completion Date:** 2022-01-31
- **CT.gov Last Update:** 2022-03-04

## 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.

## Eligibility

- **Minimum age:** 55 Years
- **Sex:** FEMALE
- **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
```

## Arms

- **Non-diabetes** (ACTIVE_COMPARATOR) — postmenopausal women with normal glucose tolerance
- **diabetes** (EXPERIMENTAL) — postmenopausal women with type 2 diabetes

## Interventions

- **Ibandronate Oral Tablet** (DRUG) — 150 mg of ibandronate + 24,000 IU of cholecalciferol

## Primary Outcomes

- **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

- **Bone turnover markers** _(time frame: 6 month and 12 month)_

## Locations (1)

- Yeouido St.Mary's Hospital, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.yeouido st.mary's hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05266261.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05266261*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*