Rheumatoid ArthritisPhase 4NCT01287533
Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids
A Phase 4 study testing Ibandronate in people with Rheumatoid Arthritis and Osteoporosis, run by Yeong-Wook Song at 1 site in South Korea.
Trial summary
This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Rheumatoid Arthritis, Osteoporosis, Osteopenia
- What is being tested?
- Ibandronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Apr 2014
- Phase
- Phase 4
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis fulfilling the 1987 ACR criteria
- Women equal and above 18 years, less than 75 years old
- L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry)
- Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year
- Patient who would be taking glucocorticoids for more than 3 months after enrollment
Who cannot join
- Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis
- Patient diagnosed with malignancy within 5 years
- Patient with endocrine dysfunction
- RA functional class 4
- Patient who took bisphosphonates within 6 months
- Patient on medication affecting bone mineral metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids
This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
Read the detailed description
Glucocorticoid therapy is associated with a number of significant side effects, of which bone loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the most serious. However studies show that many patients treated with glucocorticoids do not receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate are effective in both the prevention and the treatment of glucocorticoid-induced osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently observed in lumbar spine, were seen in patients with many different glucocorticoid-treated disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of patient age, sex and menopausal status in women. In addition, statically significant reductions in the absolute risk and relative risk of incident radiographic vertebral fractures were demonstrated after 1 year of treatment with risedronate. A similar significant reduction in the risk of incident radiographic vertebral fractures was seen in alendronate treated patients who completed 2 years of a study of alendronate in the prevention and treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which reported that intermittent intravenous ibandronate reduced vertebral fracture risk in corticosteroid-induced osteoporosis. However, there is no report about oral monthly ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide great acceptability. The objective of this study was to investigate the efficacy of oral monthly ibandronate in women receiving long-term glucocorticoids.
- Conditions
- Rheumatoid Arthritis, Osteoporosis, Osteopenia
- Being tested
- Ibandronate, Placebo
- Keywords
- Rheumatoid arthritis, Glucocorticoid induced osteoporosis, Vertebral fracture
- Medical subject headings
- Arthritis, Rheumatoid, Osteoporosis, Bone Diseases, Metabolic, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbandronateDrug
monthly dosage of ibandronate 150mg
PlaceboDrug
monthly dosage of placebo
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate treatment | Experimental | Ibandronate 150mg PO once every 4 weeks Receives: Drug: Ibandronate |
| Placebo arm | Placebo comparator | Placebo PO once every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in L1-4 bone mineral density compared with baseline
Measured: 48 weeks
Secondary outcomes (4)
Changes in femur bone mineral density compared with baseline
Measured: 48 weeks
Changes in L1-4 and femur bone mineral density compared with baseline
Measured: 24 weeks
Changes in C-telopeptide compared with baseline
Measured: 24 and 48 weeks
Cumulative incidence of vertebral fracture
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionApr 2014
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 Rheumatoid ArthritisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeong-Wook Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeong-Wook Song, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287533
- Sponsor's protocol ID
- 112942
- Status last verified
- Nov 2014
- First submitted
- 30 Jan 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shin K, Park SH, Park W, Baek HJ, Lee YJ, Kang SW, Choe JY, Yoo WH, Park YB, Song JS, Lee SG, Yoo B, Yoo DH, Song YW. Monthly Oral Ibandronate Reduces Bone Loss in Korean Women With Rheumatoid Arthritis and Osteopenia Receiving Long-term Glucocorticoids: A 48-week Double-blinded Randomized Placebo-controlled Investigator-initiated Trial. Clin Ther. 2017 Feb;39(2):268-278.e2. doi: 10.1016/j.clinthera.2017.01.008. Epub 2017 Feb 1.
PubMed 28161119
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids
- ClinicalTrials.gov ID
- NCT01287533
- Acronym / sponsor ID
- 112942
- Conditions
- Rheumatoid Arthritis, Osteoporosis, Osteopenia
- Keywords
- Rheumatoid arthritis, Glucocorticoid induced osteoporosis, Vertebral fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Yeong-Wook SongUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Feb 2011 (estimated)
- 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.
This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
Detailed description
Glucocorticoid therapy is associated with a number of significant side effects, of which bone loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the most serious. However studies show that many patients treated with glucocorticoids do not receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate are effective in both the prevention and the treatment of glucocorticoid-induced osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently observed in lumbar spine, were seen in patients with many different glucocorticoid-treated disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of patient age, sex and menopausal status in women. In addition, statically significant reductions in the absolute risk and relative risk of incident radiographic vertebral fractures were demonstrated after 1 year of treatment with risedronate. A similar significant reduction in the risk of incident radiographic vertebral fractures was seen in alendronate treated patients who completed 2 years of a study of alendronate in the prevention and treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which reported that intermittent intravenous ibandronate reduced vertebral fracture risk in corticosteroid-induced osteoporosis. However, there is no report about oral monthly ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide great acceptability. The objective of this study was to investigate the efficacy of oral monthly ibandronate in women receiving long-term glucocorticoids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate treatment | Experimental | Drug: IbandronateIbandronate 150mg PO once every 4 weeks |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo PO once every 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Rheumatoid arthritis fulfilling the 1987 ACR criteria
- Women equal and above 18 years, less than 75 years old
- L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry)
- Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year
- Patient who would be taking glucocorticoids for more than 3 months after enrollment
Key exclusion criteria (6 listed)
- Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis
- Patient diagnosed with malignancy within 5 years
- Patient with endocrine dysfunction
- RA functional class 4
- Patient who took bisphosphonates within 6 months
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 |
|---|---|---|
| Ibandronatemonthly dosage of ibandronate 150mg | Drug | Ibandronate treatment |
| Placebomonthly dosage of placebo | Drug | Placebo arm |
Primary outcome
Changes in L1-4 bone mineral density compared with baseline
Time frame: 48 weeks
4 secondary outcomes
Changes in femur bone mineral density compared with baseline
Time frame: 48 weeks
Changes in L1-4 and femur bone mineral density compared with baseline
Time frame: 24 weeks
Changes in C-telopeptide compared with baseline
Time frame: 24 and 48 weeks
Cumulative incidence of vertebral fracture
Time frame: 48 weeks
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 19 Nov 2014.
- Derived from this study: PubMed 28161119Shin K, Park SH, Park W, Baek HJ, Lee YJ, Kang SW, Choe JY, Yoo WH, Park YB, Song JS, Lee SG, Yoo B, Yoo DH, Song YW. Monthly Oral Ibandronate Reduces Bone Loss in Korean Women With Rheumatoid Arthritis and Osteopenia Receiving Long-term Glucocorticoids: A 48-week Double-blinded Randomized Placebo-controlled Investigator-initiated Trial. Clin Ther. 2017 Feb;39(2):268-278.e2. doi: 10.1016/j.clinthera.2017.01.008. Epub 2017 Feb 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibandronate in people with Rheumatoid Arthritis and Osteoporosis, run by Yeong-Wook Song 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 5 inclusion and 6 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 19 Nov 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in L1-4 bone mineral density compared with baseline (time frame: 48 weeks). 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 NCT01287533, 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 19 Nov 2014.