OsteoporosisNCT00837746
Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate
An observational study of Osteoporosis, run by Warner Chilcott at 8 sites in 2 countries.
Trial summary
This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- risedronate
- Type of treatment
- Pill or oral medicine
- How many people
- 29 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2003to Oct 2006
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed month 36 of Study RVN-008993.
- Underwent an iliac crest bone biopsy at month 36.
Who cannot join
- Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Nelson Watts, MD
Cincinnati, Ohio, 45219
Grattan Woodson, MD
Decatur, Georgia, 30033
Christopher Recknor, MD
Gainesville, Georgia, 30501
Paul Miller, MD
Lakewood, Colorado, 80227
Robert Recker, MD
Omaha, Nebraska, 68131
Maria Greenwald, MD
Palm Desert, California, 92260
Ronald D Emkey, MD
Wyomissing, Pennsylvania, 19610
About this study
Official title: Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly
This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.
- Conditions
- Osteoporosis
- Being tested
- risedronate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women taking risedronate for 5 years Receives: Drug: risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startApr 2003
- Primary completionOct 2006
- Study completionOct 2006
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
- Observational
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Ana M Balske, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837746
- Sponsor's protocol ID
- 2004140
- Status last verified
- Jun 2013
- First submitted
- 3 Feb 2009
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly
- ClinicalTrials.gov ID
- NCT00837746
- Acronym / sponsor ID
- 2004140
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Apr 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 5 Feb 2009 (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 analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: risedronateWomen taking risedronate for 5 years |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Completed month 36 of Study RVN-008993.
- Underwent an iliac crest bone biopsy at month 36.
Key exclusion criteria (1 listed)
- Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.
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 |
|---|---|---|
| risedronaterisedronate tablet, 5 mg daily or 35 mg once weekly for 5 years | Drug | 1 |
Primary outcome
Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate
Time frame: 5 years
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 5 Jun 2013.
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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.
Ana M Balske, MD study director
Procter and Gamble
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Warner Chilcott at 8 sites in 2 countries.
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 1 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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?
Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate (time frame: 5 years). 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 5 Jun 2013.