Postmenopausal Women With OsteoporosisPhase 3NCT01249261
Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
A Phase 3 study testing Risedronate in people with Postmenopausal Women With Osteoporosis, run by Warner Chilcott at 13 sites in 8 countries.
Trial summary
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized. Read more about this study
- Who is it for?
- Ages Up to 85 years, women only
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- Risedronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 13 sitesin 8 countries
- Study dates
- Oct 2001to May 2003
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 85 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080
Who cannot join
- Less than 60% compliant between drug start and month 21
- Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000 IU vitamin D, investigational drug
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
Poland4 sites
Investigational Site
Warsaw, Poland, PL 03-0335
Investigational Site
Warsaw, Poland, PL-02315
Investigational Site
Warsaw, Poland, PL-04-736
Investigational Site
Warsaw, Poland, PL00-909
Australia2 sites
Investigational Site
Concord, New South Wales, 2139
Investigational Site
Parkville, Victoria, 3052
Spain2 sites
Investigational Site
Barcelona, Spain, 08907
Investigational Site
Madrid, Spain, 28040
About this study
Official title: A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- Risedronate, Placebo/Risedronate
- Keywords
- Postmenopausal Women, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
5 mg/day
Placebo/RisedronateDrug
placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Risedronate | Placebo comparator | Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8 Receives: Drug: Placebo/Risedronate |
| Risedronate | Active comparator | Risedronate 5mg years 1-7, no drug year 8 Receives: Drug: Risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 6 (Year 8)
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12 (Year 8)
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Measured: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startOct 2001
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal Women With 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herman Ellman, MD, Study director, Warner Chilcott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249261
- Sponsor's protocol ID
- 2001079
- Status last verified
- Oct 2011
- First submitted
- 24 Nov 2010
- Last updated
- 2 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)
- ClinicalTrials.gov ID
- NCT01249261
- Acronym / sponsor ID
- 2001079
- Conditions
- Postmenopausal Women With Osteoporosis
- Keywords
- Postmenopausal Women, Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 29 Nov 2010 (estimated)
- Results
- Posted 26 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/Risedronate | Placebo comparator | Drug: Placebo/RisedronatePlacebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8 |
| Risedronate | Active comparator | Drug: RisedronateRisedronate 5mg years 1-7, no drug year 8 |
Who may qualify
- Ages
- Up to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080
Key exclusion criteria (2 listed)
- Less than 60% compliant between drug start and month 21
- Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000 IU vitamin D, investigational drug
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 |
|---|---|---|
| Risedronate5 mg/day | Drug | Risedronate |
| Placebo/Risedronateplacebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8 | Drug | Placebo/Risedronate |
Primary outcome
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)
Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12 (Year 8)
Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Time frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herman Ellman, MD study director
Warner Chilcott
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risedronate in people with Postmenopausal Women With Osteoporosis, run by Warner Chilcott at 13 sites in 8 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 1 inclusion and 2 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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, Australia, Spain, Belgium, Denmark and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population (time frame: Baseline Core Study (Year 1) to Month 6 (Year 8)). The study lists 12 primary outcomes in all. 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 2 Nov 2011.