OsteopeniaPhase 3NCT00386360
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
A Phase 3 study testing risedronate in people with Osteopenia, run by Warner Chilcott at 9 sites in 7 countries.
Trial summary
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Osteopenia
- 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
- 161 participants
- Where
- 9 sitesin 7 countries
- Study dates
- Apr 2006to Sep 2009
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
- osteopenic
- must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
- BMI (body mass index) between 18 and 28 kg/m2 inclusive;
Who cannot join
- history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
- clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
- glucocorticoid-induced osteopenia;
- previous bisphosphonate therapy;
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
France3 sites
Research Facility
Lyon, Lyon
Research Facility
Saint-Etienne, Saint-Etienne
Research Facility
Toulouse, Toulouse
About this study
Official title: A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
Read the detailed description
The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.
- Conditions
- Osteopenia
- Being tested
- Placebo comparator, risedronate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo comparatorDrug
oral weekly for one year
risedronateDrug
35 mg risedronate, once a week for one year
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo dose Receives: Drug: Placebo comparator |
| Risedronate | Experimental | 35 mg risedronate, orally, once weekly Receives: Drug: risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Secondary outcomes (13)
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Lumbar Spine BMD, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Femoral Neck BMD, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Greater Trochanter BMD, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
ELISA / enzyme-linked immunosorbent assay method by central lab
Measured: Baseline and Month 12
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
Electrochemiluminescence assay method by central lab
Measured: Baseline and Month 12
Height, Percent Change From Baseline to Month 12
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2009
- Study completionSep 2009
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 OsteopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gioacchino D'Alo, MD, Principal investigator, P&G Pharmaceuticals, Clinical Development Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386360
- Sponsor's protocol ID
- 2005040
- Status last verified
- Oct 2011
- First submitted
- 9 Oct 2006
- Last updated
- 11 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)
- ClinicalTrials.gov ID
- NCT00386360
- Acronym / sponsor ID
- 2005040
- Conditions
- Osteopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Posted 11 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
Detailed description
The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo comparatorPlacebo dose |
| Risedronate | Experimental | Drug: risedronate35 mg risedronate, orally, once weekly |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
- osteopenic
- must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
- BMI (body mass index) between 18 and 28 kg/m2 inclusive;
Key exclusion criteria (4 listed)
- history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
- clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
- glucocorticoid-induced osteopenia;
- previous bisphosphonate therapy;
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 comparatororal weekly for one year | Drug | Placebo |
| risedronate35 mg risedronate, once a week for one year | Drug | Risedronate |
Primary outcome
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
13 secondary outcomes
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Lumbar Spine BMD, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Femoral Neck BMD, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Greater Trochanter BMD, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Height, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- 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.
Gioacchino D'Alo, MD principal investigator
P&G Pharmaceuticals, Clinical Development Europe
9 sites in 7 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 Osteopenia, run by Warner Chilcott at 9 sites in 7 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 4 inclusion and 4 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Argentina, Australia, Canada, Germany and 2 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 11 Jan 2012). 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?
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12 (time frame: Baseline and Month 12). 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 11 Jan 2012.