OsteoporosisPhase 3OSMAUSENCT00345644
Risedronate in Osteopenic Postmenopausal Women
A Phase 3 study testing risedronate in people with Osteoporosis, run by Sanofi at 1 site in France.
Trial summary
The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT). Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- 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
- 156 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m²
Who cannot join
- Clinical or radiological evidence of osteoporosis
- Severe renal impairment
- Serum 5-hydroxy vitamin D level < 15 ng/ml
- History of recent primary hyperparathyroidism or recent thyroid disorder
- History of any generalized bone disease
- Current use of glucocorticoids, estrogens, progestins, calcium supplements > 1 g/day, vitamin D supplements > 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for > 1 month at any time within the past 6 months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo
The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).
The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:
- Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
- 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and
- Bone turnover markers (BTMs) of:
- fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
- serum aminoterminal propeptide of type 1 procollagen (PINP); and
- urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.
- Conditions
- Osteoporosis
- Being tested
- risedronate, risedronate placebo
- Keywords
- Postmenopausal
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
risedronate sodium 35 mg tablets (once a week dose)
risedronate placeboDrug
placebo for risedronate tablets (once a week dose)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: risedronate |
| 2 | Placebo comparator | Not described Receives: Drug: risedronate placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)
Measured: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12
Secondary outcomes (1)
Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures
Measured: at all visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Marie SEBILLE, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345644
- Sponsor's protocol ID
- HMR4003B_3507
- Other IDs
- EudraCT # :2005-005598-30
- Acronym
- OSMAUSE
- Status last verified
- Dec 2009
- First submitted
- 20 Mar 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. 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: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo
- ClinicalTrials.gov ID
- NCT00345644
- Acronym / sponsor ID
- OSMAUSE / HMR4003B_3507
- Conditions
- Osteoporosis
- Keywords
- Postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Mar 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).
The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:
- Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
- 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and
- Bone turnover markers (BTMs) of:
- fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
- serum aminoterminal propeptide of type 1 procollagen (PINP); and
- urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: risedronate |
| 2 | Placebo comparator | Drug: risedronate placebo |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m²
Key exclusion criteria (7 listed)
- Clinical or radiological evidence of osteoporosis
- Severe renal impairment
- Serum 5-hydroxy vitamin D level < 15 ng/ml
- History of recent primary hyperparathyroidism or recent thyroid disorder
- History of any generalized bone disease
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 |
|---|---|---|
| risedronaterisedronate sodium 35 mg tablets (once a week dose) | Drug | 1 |
| risedronate placeboplacebo for risedronate tablets (once a week dose) | Drug | 2 |
Primary outcome
Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)
Time frame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12
1 secondary outcome
Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures
Time frame: at all visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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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.
Marie SEBILLE, Dr study director
Sanofi
1 site in 1 country: 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 Osteoporosis, run by Sanofi at 1 site in France.
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 7 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 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements) (time frame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at 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 7 Dec 2009.