Other OsteoporosisPhase 3NCT00619957
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
A Phase 3 study testing Risedronate in people with Other Osteoporosis, run by Warner Chilcott at 23 sites in 10 countries.
Trial summary
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Other Osteoporosis
- What is being tested?
- Risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 23 sitesin 10 countries
- Study dates
- Jun 2002to May 2007
- 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 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented osteoporosis of the femoral neck and lumbar spine
Who cannot join
- BMI greater than or equal to 35
Trial locations and contacts
23 sites in 10 countries.
23 sites in 10 countries
United States7 sites
Research Facility
Cincinnati, Ohio, 45219
Research Site
Lakewood, Colorado, 80227
Research Site
Palm Desert, California, 92260
Research Site
Portland, Oregon, 97239
Research Site
St Louis, Missouri, 63110
Research Site
Stuart, Florida, 34996
Research Site
Wyomissing, Pennsylvania, 19610
United Kingdom3 sites
Research Site
London
Research Site
Newcastle
Research Site
Sheffield
About this study
Official title: Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
- Conditions
- Other Osteoporosis
- Being tested
- Placebo tablet, Risedronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo tabletDrug
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
RisedronateDrug
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years Receives: Drug: Placebo tablet |
| Risedronate | Experimental | 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years Receives: Drug: Risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Measured: Baseline to 24 Months/Endpoint
Secondary outcomes (36)
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Measured: Baseline to Month 6
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Measured: Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Measured: Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Measured: Baseline to Month 6
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Measured: Baseline to Month 12
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Measured: Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Measured: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008
Measured: Baseline to Month 6
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008
Measured: Baseline to Month 12
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008
Measured: Baseline to Month 24
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008
Measured: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Measured: Baseline to Month 6
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Measured: Baseline to Month 12
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Measured: Baseline to Month 24
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Measured: Baseline to 24 Months/Endpoint
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Measured: Baseline to Month 3
Percent Change From Baseline in CTx, Month 6, ITT Population.
Measured: Baseline to Month 6
Percent Change From Baseline in CTx, Month 12, ITT Population.
Measured: Baseline to Month 12
Percent Change From Baseline in CTx, Month 24, ITT Population.
Measured: Baseline to Month 24
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Measured: Baseline to 24 Months/Endpoint
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Measured: Baseline to Month 3
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Measured: Baseline to Month 6
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Measured: Baseline to Month 12
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Measured: Baseline to Month 24
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Measured: Baseline to 24 Months/Endpoint
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Measured: Baseline to Month 3
Percent Change From Baseline in BAP, Month 6, ITT Population.
Measured: Baseline to Month 6
Percent Change From Baseline in BAP, Month 12, ITT Population.
Measured: Baseline to Month 12
Percent Change From Baseline in BAP, Month 24, ITT Population.
Measured: Baseline to Month 24
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Measured: Baseline to 24 Months/Endpoint
Change From Baseline in Body Height, Month 12, ITT Population.
Measured: Baseline to Month 12
Change From Baseline in Body Height, Month 24, ITT Population.
Measured: Baseline to Month 24
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Measured: Baseline to 24 Months/Endpoint
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24
Measured: Baseline to Month 24
Cumulative Incidence of Fractures, 12 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Measured: Baseline to Month 12
Cumulative Incidence of Fractures, 24 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Measured: Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startJun 2002
- Primary completionMay 2007
- Study completionMay 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Dietrich Wenderoth, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619957
- Sponsor's protocol ID
- 2001092 and 2001092 OL
- Status last verified
- Sep 2011
- First submitted
- 11 Feb 2008
- Last updated
- 28 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.
PubMed 22750403
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study
- ClinicalTrials.gov ID
- NCT00619957
- Acronym / sponsor ID
- 2001092 and 2001092 OL
- Conditions
- Other Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jun 2002
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Posted 28 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo tabletPlacebo tablet once a week for 2 years followed by once a week Risedronate for 2 years |
| Risedronate | Experimental | Drug: Risedronate35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented osteoporosis of the femoral neck and lumbar spine
Key exclusion criteria (1 listed)
- BMI greater than or equal to 35
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 |
|---|---|---|
| Placebo tabletone placebo once a week for two years followed by one 35 mg risedronate once a week for two years | Drug | 1 |
| Risedronateone 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years | Drug | Risedronate |
Primary outcome
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
36 secondary outcomes
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Time frame: Baseline to Month 3
Percent Change From Baseline in CTx, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in CTx, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in CTx, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Time frame: Baseline to Month 3
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Time frame: Baseline to Month 3
Percent Change From Baseline in BAP, Month 6, ITT Population.
Time frame: Baseline to Month 6
Percent Change From Baseline in BAP, Month 12, ITT Population.
Time frame: Baseline to Month 12
Percent Change From Baseline in BAP, Month 24, ITT Population.
Time frame: Baseline to Month 24
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Change From Baseline in Body Height, Month 12, ITT Population.
Time frame: Baseline to Month 12
Change From Baseline in Body Height, Month 24, ITT Population.
Time frame: Baseline to Month 24
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Time frame: Baseline to 24 Months/Endpoint
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
Time frame: Baseline to Month 24
Cumulative Incidence of Fractures, 12 Months, ITT Population
Time frame: Baseline to Month 12
Cumulative Incidence of Fractures, 24 Months, ITT Population
Time frame: Baseline to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22750403Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.
Related trials for Other Osteoporosis
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.
Dietrich Wenderoth, MD study director
Procter and Gamble
23 sites in 10 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 Other Osteoporosis, run by Warner Chilcott at 23 sites in 10 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 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 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Poland, United Kingdom, Australia, France and 5 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 28 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?
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. (time frame: Baseline to 24 Months/Endpoint). 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 NCT00619957, 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 28 Oct 2011.