Systemic Lupus ErythematosusPhase 4NCT00668330
Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus
A Phase 4 study testing Ibandronate+alfacalcidol+calcium in people with Systemic Lupus Erythematosus, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The primary aim of the present study was to investigate the prevalence of low bone mineral density (BMD) and vertebral fractures, as determined by a standardized assessment, and to elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone turnover, mineralization and inflammation on… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Ibandronate+alfacalcidol+calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to May 2009
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled the ACR revised criteria for the classification of SLE
- Provided written informed consent for their participation
- Part II
- Have low BMD (T socre < -1 S.D. at the lumbar spine (L1-L4) or total hip) induced by the long-term administration of high-dose corticosteroids.
- Had been receiving chronic uninterrupted corticosteroid therapy for at least 1 year or had received a corticosteroid dose of at least 5 mg/day.
Who cannot join
- Hypocalcaemia, hypercalcaemia, Hypercalciuria, a creatinine clearance of less than 30 ml per minute.
- A history of nephrolithiasis during the previous five years.
- A history of recent major gastrointestinal (GI) tract disease (e.g. oesophagitis).
- Had or presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began.
- Had experienced any previous adverse reaction to bisphosphonate therapy (alendronate, fosamax, ibandronate).
- With uncontrolled active or recurrent peptic ulcer disease.
- Receiving therapy (within the last 6 months) known to affect bone metabolism, including:hormone-replacement agents, calcitonin, active vitamin D3 analogues, thiazide diuretics,treatment with bisphosphonates,fluoride treatment within the last 12 mons or for a total duration of 2 years; contraindications to calcium or vitamin D therapy.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment
The primary aim of the present study was to investigate the prevalence of low bone mineral density (BMD) and vertebral fractures, as determined by a standardized assessment, and to elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone turnover, mineralization and inflammation on bone density and prevalent vertebral fractures in a large population of systemic lupus erythematosus (SLE) patients.
The secondary aim of the study is to evaluate the following parameters in women with steroid induced OP (SIOP) before and after 1 year of treatment using:
- The changes in BMD using dual energy X-ray absorptiometry (DXA)
- Bone mineralization and architecture in-vivo using a newly available high-resolution human micro-computed tomography (ExtremCT), which can provide us with new insights into how the degree and distribution of mineralization are affected by long-term oral Ibandronate treatment.
- Changes in perfusion and marrow edema before and after treatment of Ibandronate using dynamic Magnetic Resonance Imaging (MRI) in these patients with SIOP.
- The investigators prospectively evaluate the correlation between the changes in brachial arterial endothelial function and lumbar spine BMD in female lupus patients over the period of 1 year.
Read the detailed description
In the first part of the study, 150 consecutive patients with a diagnosis of SLE were included in the study. All patients fulfilled the American College of Rheumatology (ACR) revised criteria for the classification of SLE and provided written informed consent. Data collected at the time of study inclusion were age, disease duration, race, menstrual status, age at menopause, periods of amenorrhea, family history of osteoporosis, ultraviolet (UV) light intolerance, sunshine avoidance, use of sunscreens in the previous year, calculated mean daily dietary calcium intake in the last 3 months, history of (non)vertebral fractures after the age of 25 years, comorbidity, alcohol and tobacco intake, and exercise status.Body weight, height, and body mass index (BMI) were assessed. Disease activity was scored using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 54. Accumulated organ damage was assessed with the SLICC/ ACR damage index (DI) 55. A modified DI score was derived as the DI score excluding osteoporotic fractures as a damage item.BMD measurements of the hip (total hip and femoral neck) and the lumbar spine (L1-4; anteroposterior view) as well as lateral radiographs of the thoracic and lumbar spine (T5-L4)were performed. The prevalence of low BMD and vertebral fractures will be assessed.
In the second part of the study, 40 female SLE patients with steroid induced osteopenia will be enrolled in a 12-month, randomized, parallel-group, controlled study. Patients will receive either oral Ibandronate 150 mg once monthly plus daily alfacalcidol (0.001 mg) or placebo ibandronate once monthly plus daily alfacalcidol(0.001mg).In addition, the intake of dietary calcium will estimate by a questionnaire on the screening visit. All patients will receive a daily calcium supplement(500 mg).
Primary outcome is the improvement of bone mineral density measured by DEXA.
Secondary outcome includes:
- Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT.
- Evaluation of the changes in perfusion and marrow edema using MRI.
- Anti-proliferative and anti-inflammatory action of alfacalcidol using serum level of interleukin-6 (IL-6), transforming growth factor-beta-1, angiotensin-II, as well as urinary levels of TGF and monocyte chemoattractant protein-1 (MCP-1).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Ibandronate+alfacalcidol+calcium, placebo ibandronate+alfacalcidol+calcium
- Keywords
- Bone mineral density, ibandronate, alfacalcidol
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronate+alfacalcidol+calciumDrug
Also called Bonviva
Ibandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg plus calcium
placebo ibandronate+alfacalcidol+calciumDrug
Also called placebo Bonviva
placebo ibandronate monthly plus daily alfacalcidol(1ug)500mg calcium
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate+alfacalcidol+calcium | Active comparator | Bonviva Receives: Drug: Ibandronate+alfacalcidol+calcium; Drug: placebo ibandronate+alfacalcidol+calcium |
| Placebo ibandronate+alfacalcidol+calcium | Active comparator | Not described Receives: Drug: Ibandronate+alfacalcidol+calcium; Drug: placebo ibandronate+alfacalcidol+calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of Part I study is to investigate the prevalence of low BMD and vertebral fractures. Primary outcome of part II study is the improvement of bone mineral density measured by DEXA.
Measured: baseline and month 12
Secondary outcomes (2)
Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT.
The study will be analyzed using intention-to-treat (ITT) analysis
Measured: baseline, month 6 and month 12
Evaluation of the changes in perfusion and marrow edema using MRI.
The study will be analyzed using intention-to-treat (ITT) analysis
Measured: baseline, month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMay 2009
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 Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-Shan Tam, Chinese University of Hong Kong
- Investigators
- Edmund K Li, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668330
- Sponsor's protocol ID
- SLE-2007-007
- Status last verified
- Feb 2012
- First submitted
- 25 Apr 2008
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Li EK, Zhu TY, Hung VY, Kwok AW, Lee VW, Lee KK, Griffith JF, Li M, Wong KC, Leung PC, Qin L, Tam LS. Ibandronate increases cortical bone density in patients with systemic lupus erythematosus on long-term glucocorticoid. Arthritis Res Ther. 2010;12(5):R198. doi: 10.1186/ar3170. Epub 2010 Oct 22.
PubMed 20964867
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment
- ClinicalTrials.gov ID
- NCT00668330
- Acronym / sponsor ID
- SLE-2007-007
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Bone mineral density, ibandronate, alfacalcidol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Apr 2008 (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.
The primary aim of the present study was to investigate the prevalence of low bone mineral density (BMD) and vertebral fractures, as determined by a standardized assessment, and to elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone turnover, mineralization and inflammation on bone density and prevalent vertebral fractures in a large population of systemic lupus erythematosus (SLE) patients.
The secondary aim of the study is to evaluate the following parameters in women with steroid induced OP (SIOP) before and after 1 year of treatment using:
- The changes in BMD using dual energy X-ray absorptiometry (DXA)
- Bone mineralization and architecture in-vivo using a newly available high-resolution human micro-computed tomography (ExtremCT), which can provide us with new insights into how the degree and distribution of mineralization are affected by long-term oral Ibandronate treatment.
- Changes in perfusion and marrow edema before and after treatment of Ibandronate using dynamic Magnetic Resonance Imaging (MRI) in these patients with SIOP.
- The investigators prospectively evaluate the correlation between the changes in brachial arterial endothelial function and lumbar spine BMD in female lupus patients over the period of 1 year.
Detailed description
In the first part of the study, 150 consecutive patients with a diagnosis of SLE were included in the study. All patients fulfilled the American College of Rheumatology (ACR) revised criteria for the classification of SLE and provided written informed consent. Data collected at the time of study inclusion were age, disease duration, race, menstrual status, age at menopause, periods of amenorrhea, family history of osteoporosis, ultraviolet (UV) light intolerance, sunshine avoidance, use of sunscreens in the previous year, calculated mean daily dietary calcium intake in the last 3 months, history of (non)vertebral fractures after the age of 25 years, comorbidity, alcohol and tobacco intake, and exercise status.Body weight, height, and body mass index (BMI) were assessed. Disease activity was scored using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 54. Accumulated organ damage was assessed with the SLICC/ ACR damage index (DI) 55. A modified DI score was derived as the DI score excluding osteoporotic fractures as a damage item.BMD measurements of the hip (total hip and femoral neck) and the lumbar spine (L1-4; anteroposterior view) as well as lateral radiographs of the thoracic and lumbar spine (T5-L4)were performed. The prevalence of low BMD and vertebral fractures will be assessed.
In the second part of the study, 40 female SLE patients with steroid induced osteopenia will be enrolled in a 12-month, randomized, parallel-group, controlled study. Patients will receive either oral Ibandronate 150 mg once monthly plus daily alfacalcidol (0.001 mg) or placebo ibandronate once monthly plus daily alfacalcidol(0.001mg).In addition, the intake of dietary calcium will estimate by a questionnaire on the screening visit. All patients will receive a daily calcium supplement(500 mg).
Primary outcome is the improvement of bone mineral density measured by DEXA.
Secondary outcome includes:
- Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT.
- Evaluation of the changes in perfusion and marrow edema using MRI.
- Anti-proliferative and anti-inflammatory action of alfacalcidol using serum level of interleukin-6 (IL-6), transforming growth factor-beta-1, angiotensin-II, as well as urinary levels of TGF and monocyte chemoattractant protein-1 (MCP-1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate+alfacalcidol+calcium | Active comparator | Drug: Ibandronate+alfacalcidol+calcium, Drug: placebo ibandronate+alfacalcidol+calciumBonviva |
| Placebo ibandronate+alfacalcidol+calcium | Active comparator | Drug: Ibandronate+alfacalcidol+calcium, Drug: placebo ibandronate+alfacalcidol+calcium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfilled the ACR revised criteria for the classification of SLE
- Provided written informed consent for their participation
- Part II
- Have low BMD (T socre < -1 S.D. at the lumbar spine (L1-L4) or total hip) induced by the long-term administration of high-dose corticosteroids.
- Had been receiving chronic uninterrupted corticosteroid therapy for at least 1 year or had received a corticosteroid dose of at least 5 mg/day.
Key exclusion criteria (8 listed)
- Hypocalcaemia, hypercalcaemia, Hypercalciuria, a creatinine clearance of less than 30 ml per minute.
- A history of nephrolithiasis during the previous five years.
- A history of recent major gastrointestinal (GI) tract disease (e.g. oesophagitis).
- Had or presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began.
- Had experienced any previous adverse reaction to bisphosphonate therapy (alendronate, fosamax, ibandronate).
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+alfacalcidol+calciumAlso: BonvivaIbandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg plus calcium | Drug | Ibandronate+alfacalcidol+calcium, Placebo ibandronate+alfacalcidol+calcium |
| placebo ibandronate+alfacalcidol+calciumAlso: placebo Bonvivaplacebo ibandronate monthly plus daily alfacalcidol(1ug)500mg calcium | Drug | Ibandronate+alfacalcidol+calcium, Placebo ibandronate+alfacalcidol+calcium |
Primary outcome
The primary outcome of Part I study is to investigate the prevalence of low BMD and vertebral fractures. Primary outcome of part II study is the improvement of bone mineral density measured by DEXA.
Time frame: baseline and month 12
2 secondary outcomes
Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT.
Time frame: baseline, month 6 and month 12
Evaluation of the changes in perfusion and marrow edema using MRI.
Time frame: baseline, month 6, month 12
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 13 Feb 2012.
- Derived from this study: PubMed 20964867Li EK, Zhu TY, Hung VY, Kwok AW, Lee VW, Lee KK, Griffith JF, Li M, Wong KC, Leung PC, Qin L, Tam LS. Ibandronate increases cortical bone density in patients with systemic lupus erythematosus on long-term glucocorticoid. Arthritis Res Ther. 2010;12(5):R198. doi: 10.1186/ar3170. Epub 2010 Oct 22.
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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.
Edmund K Li, MD principal investigator
Chinese University of Hong Kong
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+alfacalcidol+calcium in people with Systemic Lupus Erythematosus, run by Chinese University of Hong Kong at 1 site in China.
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 8 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 13 Feb 2012. 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 China. 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.
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?
The primary outcome of Part I study is to investigate the prevalence of low BMD and vertebral fractures. Primary outcome of part II study is the improvement of bone mineral density measured by DEXA. (time frame: baseline and month 12). 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 NCT00668330, 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 13 Feb 2012.