OsteoporosisPhase 4NCT00372372
The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
A Phase 4 study testing risedronate in people with Osteoporosis, run by Tuen Mun Hospital at 1 site in China.
Trial summary
The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- risedronate
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2004to Apr 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (>=0.8mg/kg/day) or equivalent for at least 6 weeks.
- Age>=18 years and <75 years.
Who cannot join
- Pregnant or lactating women.
- Uncorrected hypocalcemia.
- History of esophageal stricture.
- Previous intolerance or hypersenstivity to biphosphonates.
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment
Read the detailed description
We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases
- Conditions
- Osteoporosis
- Being tested
- risedronate
- Keywords
- corticosteroids, bone mineral, risedronate, bisphosphonate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
Secondary outcomes (1)
Adverse events, new vertebral fractures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJan 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Investigators
- CC Mok, MD FRCP, Principal investigator, Tuen Mun Hospital Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372372
- Sponsor's protocol ID
- HARECCTR0500019
- Status last verified
- Sep 2007
- First submitted
- 5 Sep 2006
- Last updated
- 28 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
- ClinicalTrials.gov ID
- NCT00372372
- Acronym / sponsor ID
- HARECCTR0500019
- Conditions
- Osteoporosis
- Keywords
- corticosteroids, bone mineral, risedronate, bisphosphonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Jan 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 6 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.
The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment
Detailed description
We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (>=0.8mg/kg/day) or equivalent for at least 6 weeks.
- Age>=18 years and <75 years.
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Uncorrected hypocalcemia.
- History of esophageal stricture.
- Previous intolerance or hypersenstivity to biphosphonates.
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 |
|---|---|---|
| risedronate | Drug | – |
Primary outcome
bone mineral density
1 secondary outcome
Adverse events, new vertebral fractures
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 28 Sep 2007.
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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 risedronate 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 2 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 28 Sep 2007. 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?
bone mineral density. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2007.