Postmenopausal OsteoporosisNCT00778154
Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
An observational study of Postmenopausal Osteoporosis, run by Warner Chilcott at 8 sites in 2 countries.
Trial summary
Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and the hip by DXA. Each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- How many people
- 105 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2004to Dec 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
Study population: Outpatients from bone research centers who have taken alendronate or risedronate for 3 to 5 or more years
Who may be able to join
- Women at least 5 years postmenopausal
- Subjects treated with any combination alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for 3-5 years. Or subjects treated with any combination of alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for greater than 5 years.
Who cannot join
- Presence of metabolic bone disease other than PMO
- Use of any medication other than alendronate or risedronate within with in the past 6 months likely to interfere with skeletal homeostasis.
- Uncontrolled hyperthyroidism. Previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin.
- Alcohol or drug abuse, current or within the past 5 years.
- Allergy to tetracycline, Novocain, or Versed.
- Hip anatomy not conducive to transiliac bone biopsy or DXA scan.
- Previous bilateral transiliac bone biopsies.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Warner Chilcott Research Facility
Cincinnati, Ohio, 45219
Warner Chilcott Research Facility
Decatur, Georgia, 30033
Warner Chilcott Research Facility
Gainesville, Georgia, 30501
Warner Chilcott Research Facility
Lakewood, Colorado, 80227
Warner Chilcott Research Facility
Omaha, Nebraska, 68131
Warner Chilcott Research Facility
Palm Desert, California, 92269
Warner Chilcott Research Facility
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate
Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and the hip by DXA. Each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy procedure will be repeated.
- Conditions
- Postmenopausal Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate 3 to < 5 years | Alendronate (any combination of 10 mg daily or 70 mg once weekly) 3- 5 years. | |
| Risedronate 3 to < 5 Years | Risedronate (any combination of 5 mg daily or 35 mg once weekly) 3-5 years. | |
| Alendronate ≥ 5 Years | Alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than or equal to 5 years. | |
| Risedronate ≥ 5 Years | Risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than or equal to 5 years. |
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 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate
Measured: one year
Secondary outcomes (1)
Compare iliac crest bone histomorphometry and bone quality changes after 5 years of more of alendronate or risedronate therapy with 3 years of therapy in PMO women
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Stephen R Marcello, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778154
- Sponsor's protocol ID
- 2003096
- Status last verified
- Jun 2013
- First submitted
- 21 Oct 2008
- 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
- A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate
- ClinicalTrials.gov ID
- NCT00778154
- Acronym / sponsor ID
- 2003096
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jan 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 23 Oct 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.
Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and the hip by DXA. Each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy procedure will be repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alendronate 3 to < 5 years | – | –Alendronate (any combination of 10 mg daily or 70 mg once weekly) 3- 5 years. |
| Risedronate 3 to < 5 Years | – | –Risedronate (any combination of 5 mg daily or 35 mg once weekly) 3-5 years. |
| Alendronate ≥ 5 Years | – | –Alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than or equal to 5 years. |
| Risedronate ≥ 5 Years | – | –Risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than or equal to 5 years. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients from bone research centers who have taken alendronate or risedronate for 3 to 5 or more years
Key inclusion criteria (2 listed)
- Women at least 5 years postmenopausal
- Subjects treated with any combination alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for 3-5 years. Or subjects treated with any combination of alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for greater than 5 years.
Key exclusion criteria (7 listed)
- Presence of metabolic bone disease other than PMO
- Use of any medication other than alendronate or risedronate within with in the past 6 months likely to interfere with skeletal homeostasis.
- Uncontrolled hyperthyroidism. Previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin.
- Alcohol or drug abuse, current or within the past 5 years.
- Allergy to tetracycline, Novocain, or Versed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate
Time frame: one year
1 secondary outcome
Compare iliac crest bone histomorphometry and bone quality changes after 5 years of more of alendronate or risedronate therapy with 3 years of therapy in PMO women
Time frame: one year
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.
Stephen R Marcello, 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 Postmenopausal 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 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 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 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate (time frame: one year). 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.