Postmenopausal OsteoporosisPhase 3NCT00247273
A Study of Monthly Risedronate for Osteoporosis
A Phase 3 study testing risedronate in people with Postmenopausal Osteoporosis, run by Warner Chilcott at 49 sites in 14 countries.
Trial summary
The purpose of this trial is to study the efficacy of a single-dose monthly 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,294 participants
- Where
- 49 sitesin 14 countries
- Study dates
- Oct 2005to Apr 2008
- 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 BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine 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 (body mass index) >32 kg/m^2
- 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
49 sites in 14 countries.
49 sites in 14 countries
United States7 sites
Research Site
Bethesda, Maryland, 20817
Research Site
Cincinnati, Ohio, 45219
Research Site
Gainesville, Georgia, 30501
Research Site
Lakewood, Colorado, 80227
Research Site
Omaha, Nebraska, 068131
Research Site
Portland, Oregon, 97212
Research Site
West Haverstraw, New York, 10983
France6 sites
Research Site
Amiens
Research Site
Lyon
Research Site
Orléans
Research Site
Paris
Research Site
Toulouse
Research Site
Vandœuvre-lès-Nancy
Belgium5 sites
Research Site
Brussels
Research Site
Ghent
Research Site
Leuven
Research Site
Liège
Research Site
Mont Godinne
Hungary5 sites
Research Site
Balatonfüred
Research Site
Budapest
Research Site
Győr
Research Site
Miskolc
Research Site
Nagykanizs
Canada4 sites
Research Site
Calgary
Research Site
Montreal
Research Site
Sainte-Foy
Research Site
Saskatoon
Finland4 sites
Research Site
Helsinki
Research Site
Kuopio
Research Site
Oulu
Research Site
Turku
Australia3 sites
Research Site
Geelong
Research Site
Heidelberg, Victoria
Research Site
Saint Leonards
Argentina2 sites
Research Site
Buenos Aires, Buenos Aires
Research Site
Capital Federal
About this study
Official title: A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
The purpose of this trial is to study the efficacy of a single-dose monthly 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 150 mg monthly and 5 mg daily.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- risedronate
- Keywords
- randomized controlled trial, osteoporosis, risedronate
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
tablet, 5 mg risedronate, once a day for 2 years
risedronateDrug
oral, 150 mg risedronate, once a month for 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 5 mg risedronate, once daily for 2 years Receives: Drug: risedronate |
| 2 | Experimental | 150 mg risedronate taken once a month 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) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Measured: Baseline to Month 12 - Endpoint
Secondary outcomes (19)
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Measured: Baseline to Month 12
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Measured: Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).
Measured: Baseline to Month 24 - Endpoint
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Measured: Baseline to Month 24
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Measured: Baseline to Month 24
Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine
Measured: Baseline to Month 6
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
Measured: Baseline to Month 6
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
Measured: Baseline to Month 24
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
Measured: Baseline to Month 24
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
Measured: Baseline to Month 6
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Assayed by electrochemiluminescent immunoassay.
Measured: Baseline to Month 6
Change From Baseline in Serum CTX at Month 24, ITT Population
Assayed by electrochemiluminescent immunoassay.
Measured: Baseline to Month 24
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Assayed by electrochemiluminescent immunoassay.
Measured: Baseline to Month 24
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to Month 6
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to Month 6
Change From Baseline in Serum BAP at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to Month 24
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to Month 24
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
At least 1 new fractured vertebra
Measured: Baseline to Month 12
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
At least 1 new fractured vertebra
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 posted1 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2008
- Study completionApr 2008
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 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
- 1,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Sal Bartelmo, MD, Study director, P&G
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247273
- Sponsor's protocol ID
- 2005032
- Other IDs
- EFC6062 AND HMRF004M/3001
- Status last verified
- Apr 2013
- First submitted
- 28 Oct 2005
- Last updated
- 22 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
- ClinicalTrials.gov ID
- NCT00247273
- Acronym / sponsor ID
- 2005032
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- randomized controlled trial, osteoporosis, risedronate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,294 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Oct 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Posted 21 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Detailed description
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: risedronate5 mg risedronate, once daily for 2 years |
| 2 | Experimental | Drug: risedronate150 mg risedronate taken once a month for 2 years |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female: 50 years of age or older
- >5 years since last menses natural or surgical
- have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Key exclusion criteria (5 listed)
- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- BMI (body mass index) >32 kg/m^2
- 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
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 |
|---|---|---|
| risedronatetablet, 5 mg risedronate, once a day for 2 years | Drug | 1 |
| risedronateoral, 150 mg risedronate, once a month for 2 years | Drug | 1, 2 |
Primary outcome
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
Time frame: Baseline to Month 12 - Endpoint
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
19 secondary outcomes
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Time frame: Baseline to Month 12
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Time frame: Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
Time frame: Baseline to Month 24 - Endpoint
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Time frame: Baseline to Month 24
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Time frame: Baseline to Month 24
Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
Time frame: Baseline to Month 6
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
Time frame: Baseline to Month 6
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Time frame: Baseline to Month 24
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Time frame: Baseline to Month 24
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
Time frame: Baseline to Month 6
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Time frame: Baseline to Month 6
Change From Baseline in Serum CTX at Month 24, ITT Population
Time frame: Baseline to Month 24
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Time frame: Baseline to Month 24
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
Time frame: Baseline to Month 6
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Time frame: Baseline to Month 6
Change From Baseline in Serum BAP at Month 24, ITT Population
Time frame: Baseline to Month 24
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Time frame: Baseline to Month 24
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
Time frame: Baseline to Month 12
Number of Participants With New Vertebral Fracture at Month 24, 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 22 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Romosozumab and Denosumab Combination Therapy for Osteoporosis
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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.
Sal Bartelmo, MD study director
P&G
49 sites in 14 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 Osteoporosis, run by Warner Chilcott at 49 sites in 14 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 49 sites in United States, France, Belgium, Hungary, Canada and 9 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 in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population (time frame: Baseline to Month 12 - Endpoint). 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 22 Apr 2013.