OsteoporosisPhase 4NCT00371956
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
A Phase 4 study testing raloxifene in people with Osteoporosis, run by Tuen Mun Hospital at 1 site in China.
Trial summary
This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- raloxifene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Sep 2006to Feb 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
- Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).
- Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.
Who cannot join
- Patients with a history of thromboembolism.
- Patients with positive antiphospholipid antibodies.
- History of allergic reactions or intolerance to raloxifene or other SERMs.
- Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with abnormal uterine bleeding of unknown etiology.
- Patients with serum creatinine level of >= 200 umol/L.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study
This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.
- Conditions
- Osteoporosis
- Being tested
- raloxifene, placebo
- Keywords
- raloxifene, estrogen, receptor, modulation, osteoporosis, steroid, Steroids
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raloxifeneDrug
60mg/day
placeboDrug
tab 1 daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | raloxifene Receives: Drug: raloxifene |
| 2 | Placebo comparator | placebo arm Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone turnover and bone mineral density
Measured: 12 months
Secondary outcomes (1)
Fracture, safety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2010
- Study completionFeb 2010
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 OsteoporosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Collaborators
- Eli Lilly and Company
- Investigators
- CC MOK, MD, FRCP, Principal investigator, Tuen Mun Hospital Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371956
- Sponsor's protocol ID
- HARECCTR0500058
- Status last verified
- Sep 2010
- First submitted
- 1 Sep 2006
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. Raloxifene for prevention of glucocorticoid-induced bone loss: a 12-month randomised double-blinded placebo-controlled trial. Ann Rheum Dis. 2011 May;70(5):778-84. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.
PubMed 21187295
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00371956
- Acronym / sponsor ID
- HARECCTR0500058
- Conditions
- Osteoporosis
- Keywords
- raloxifene, estrogen, receptor, modulation, osteoporosis, steroid, Steroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Sep 2006 (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 is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: raloxifeneraloxifene |
| 2 | Placebo comparator | Drug: placeboplacebo arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
- Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).
- Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.
Key exclusion criteria (7 listed)
- Patients with a history of thromboembolism.
- Patients with positive antiphospholipid antibodies.
- History of allergic reactions or intolerance to raloxifene or other SERMs.
- Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
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 |
|---|---|---|
| raloxifene60mg/day | Drug | 1 |
| placebotab 1 daily | Drug | 2 |
Primary outcome
Bone turnover and bone mineral density
Time frame: 12 months
1 secondary outcome
Fracture, safety
Time frame: 12 months
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 16 Sep 2010.
- Derived from this study: PubMed 21187295Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. Raloxifene for prevention of glucocorticoid-induced bone loss: a 12-month randomised double-blinded placebo-controlled trial. Ann Rheum Dis. 2011 May;70(5):778-84. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.
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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.
CC MOK, MD, FRCP principal investigator
Tuen Mun Hospital 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 raloxifene in people with Osteoporosis, run by Tuen Mun Hospital 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 3 inclusion and 7 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 16 Sep 2010. 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. 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?
Bone turnover and bone mineral density (time frame: 12 months). 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 NCT00371956, 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 16 Sep 2010.