Osteoporosis, PostmenopausalNCT05266261
Use of Ibandronate in Diabetic Patients
A study testing Ibandronate Oral Tablet in people with Osteoporosis, Postmenopausal and Type 2 Diabetes, run by Yeouido St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Type 2 Diabetes
- What is being tested?
- Ibandronate Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of at least 55 years at the time of screening
- postmenopausal woman
- diagnosis of osteoporosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal, Type 2 Diabetes
- Being tested
- Ibandronate Oral Tablet
- Medical subject headings
- Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronate Oral TabletDrug
Also called daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol
150 mg of ibandronate + 24,000 IU of cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetes | Active comparator | postmenopausal women with normal glucose tolerance Receives: Drug: Ibandronate Oral Tablet |
| diabetes | Experimental | postmenopausal women with type 2 diabetes Receives: Drug: Ibandronate Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Bone turnover markers
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.
Measured: 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Oct 2018
- Primary completion30 Aug 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeouido St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki-Hyun Baek, M.D., Ph.D., Principal investigator, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266261
- Sponsor's protocol ID
- SC18MEDV0024
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Publications
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.
PubMed 35410197
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
- ClinicalTrials.gov ID
- NCT05266261
- Acronym / sponsor ID
- SC18MEDV0024
- Conditions
- Osteoporosis, Postmenopausal, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Yeouido St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Seoul National University Bundang Hospital
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetes | Active comparator | Drug: Ibandronate Oral Tabletpostmenopausal women with normal glucose tolerance |
| diabetes | Experimental | Drug: Ibandronate Oral Tabletpostmenopausal women with type 2 diabetes |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age of at least 55 years at the time of screening
- postmenopausal woman
- diagnosis of osteoporosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibandronate Oral TabletAlso: daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol150 mg of ibandronate + 24,000 IU of cholecalciferol | Drug | Non-diabetes, diabetes |
Primary outcome
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.
1 secondary outcome
Bone turnover markers
Time frame: 6 month and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 35410197Kim 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.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-Hyun Baek, M.D., Ph.D. principal investigator
Yeouido St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibandronate Oral Tablet in people with Osteoporosis, Postmenopausal and Type 2 Diabetes, run by Yeouido St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05266261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.