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Postmenopausal OsteoporosisPhase 3NCT00541658

A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

A Phase 3 study testing risedronate in people with Postmenopausal Osteoporosis, run by Warner Chilcott at 45 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
risedronate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
923 participants
Where
45 sitesin 8 countries
Study dates
Oct 2007to Apr 2010
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 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female: 50 years of age or older
  • >5 years since last menses natural or surgical
  • have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Who cannot join

  • history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
  • BMI >32 kg/m
  • use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
  • hypocalcemia or hypercalcemia of any cause
  • markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Trial locations and contacts

45 sites in 8 countries.

45 sites in 8 countries

United States20 sites

  • Research Site

    Bethesda, Maryland

  • Research Site

    Birmingham, Alabama

  • Research Site

    Brockton, Massachusetts

  • Research Site

    Champaign, Illinois

  • Research Site

    Chicago, Illinois

  • Research Site

    Gainesville, Georgia

  • Research Site

    Greenville, North Carolina

  • Research Site

    Lakewood, Colorado

  • Research Site

    Las Vegas, Nevada

  • Research Site

    Leesburg, Florida

  • Research Site

    Madison, Wisconsin

  • Research Site

    Melbourne, Florida

  • Research Site

    Oakland, California

  • Research Site

    Omaha, Nebraska

  • Research Site

    Portland, Oregon

  • Research Site

    San Diego, California

  • Research Site

    Seattle, Washington

  • Research Site

    South Miami, Florida

  • Research Facility

    Walnut Creek, California

  • Research Site

    Walnut Creek, California

Other trials in United States

Canada7 sites

  • Research Site

    Hamilton, Ontario

  • Research Site

    Kitchener, Ontario

  • Research Site

    Montreal, Quebec

  • Research Site

    Newmarket, Ontario

  • Research Site

    Québec, Quebec

  • Research Site

    Saint-Eustache, Quebec

  • Research Site

    Saskatoon, Saskatchewan

Other trials in Canada

Hungary5 sites

  • Research Site

    Balatonfüred

  • Research Site

    Debrecen

  • Research Site

    Eger

  • Research Site

    Győr

  • Research Site

    Koranyi Sandor

Other trials in Hungary

France4 sites

  • Research Site

    Amiens

  • Research Site

    Lyon

  • Research Site

    Orléans

  • Research Site

    Vandœuvre-lès-Nancy

Other trials in France

Belgium3 sites

  • Research Facility

    Diepenbeek

  • Research Site

    Ghent

  • Research Site

    Leuven

Other trials in Belgium

Estonia3 sites

  • Research Site

    Pärnu

  • Research Site

    Tallinn

  • Research Site

    Tartu

Other trials in Estonia

Poland2 sites

  • Research Site

    Bialystok

  • Research Site

    Warsaw

Other trials in Poland

Argentina1 site

  • Research Site

    Buenos Aires

Other trials in Argentina

About this study

Official title: A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Read the detailed description

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Being tested
risedronate
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • risedronateDrug

    Also called IRBB

    5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily

  • risedronateDrug

    Also called DRFB

    35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly

  • risedronateDrug

    Also called DRBB

    35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Study groups in NCT00541658
Study groupRoleWhat they receive
5 mg Before BreakfastActive comparator5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
Receives: Drug: risedronate
35 mg After BreakfastExperimental35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
Receives: Drug: risedronate
35 mg Before BreakfastExperimental35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
Receives: Drug: risedronate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population

    Measured: 52 weeks / Endpoint

Secondary outcomes (50)

  1. Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  2. Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population

    Measured: Week 26

  3. Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population

    Measured: Week 52

  4. Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population

    Measured: Week 104

  5. Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  6. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    Measured: Week 52

  7. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    Measured: Week 52 / Endpoint

  8. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    Measured: Week 52

  9. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    Measured: Week 52 / Endpoint

  10. Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population

    Measured: Week 26

  11. Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population

    Measured: Week 52

  12. Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  13. Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population

    Measured: Week 104

  14. Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  15. Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population

    Measured: Week 26

  16. Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population

    Measured: Week 52

  17. Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  18. Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population

    Measured: Week 104

  19. Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  20. Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population

    Measured: Week 26

  21. Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population

    Measured: Week 52

  22. Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint

    Measured: Week 52 / Endpoint

  23. Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population

    Measured: Week 104

  24. Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint

    Measured: Week 104 / Endpoint

  25. Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population

    Measured: Week 13

  26. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population

    Measured: Week 26

  27. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population

    Measured: Week 52

  28. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  29. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population

    Measured: Week 104

  30. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  31. Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population

    Measured: Week 13

  32. Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population

    Measured: Week 26

  33. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population

    Measured: Week 52

  34. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  35. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population

    Measured: Week 104

  36. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  37. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population

    Measured: Week 13

  38. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population

    Measured: Week 26

  39. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population

    Measured: Week 52

  40. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  41. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population

    Measured: Week 104

  42. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  43. Number of Patients With at Least One New Fractured Vertebra, Week 52

    Measured: Week 52

  44. Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population

    Measured: Week 52 / Endpoint

  45. Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population

    Measured: Week 104

  46. Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population

    Measured: Week 104 / Endpoint

  47. Number of Patients With No New Fractured Vertebra, Week 52

    Measured: Week 52

  48. Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint

    Measured: Week 52 / Endpoint

  49. Number of Patients With No New Fractured Vertebra, Week 104

    Measured: Week 104

  50. Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint

    Measured: Week 104 / Endpoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
923 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541658
Sponsor's protocol ID
2007008
Status last verified
Apr 2013
First submitted
5 Oct 2007
Last updated
22 Apr 2013
Data monitoring committee
No

Publications

  • McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.

    PubMed 21947137

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risedronate in people with Postmenopausal Osteoporosis, run by Warner Chilcott at 45 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 3 inclusion and 5 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Canada, Hungary, France, Belgium 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. 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 21 Jun 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 Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population (time frame: 52 weeks / 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 NCT00541658, 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 22 Apr 2013.

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