Use of Ibandronate in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Osteoporosis, Postmenopausal Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-diabetes

postmenopausal women with normal glucose tolerance

Group Type ACTIVE_COMPARATOR

Ibandronate Oral Tablet

Intervention Type DRUG

150 mg of ibandronate + 24,000 IU of cholecalciferol

diabetes

postmenopausal women with type 2 diabetes

Group Type EXPERIMENTAL

Ibandronate Oral Tablet

Intervention Type DRUG

150 mg of ibandronate + 24,000 IU of cholecalciferol

Interventions

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Ibandronate Oral Tablet

150 mg of ibandronate + 24,000 IU of cholecalciferol

Intervention Type DRUG

Other Intervention Names

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daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No