OsteoporosisPhase 2NCT00100607
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
A Phase 2 study testing AAE581 in people with Osteoporosis, run by Novartis Pharmaceuticals.
Trial summary
This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- AAE581
- How many people
- 676 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Sep 2005
- Phase
- Phase 2
- 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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMD T Score between -2 to -3.5
- 50-75 years old
Who cannot join
- Urolithiasis
- Bisphosphonates
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- AAE581
- Keywords
- osteoporosis/osteopenia, BMD, postmenopausal
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAE581Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine BMD and total hip BMD after 1 year treatment
Safety and tolerability of one year treatment with different doses
Secondary outcomes (4)
Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
Effect of the different doses on markers for bone formation and bone resorption
Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
Histological information on bone biopsy after 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2005 (estimated)
- Study startFeb 2004
- Primary completionSep 2005
- Study completionSep 2005
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 Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100607
- Sponsor's protocol ID
- CAAE581A2203
- Status last verified
- May 2012
- First submitted
- 3 Jan 2005
- Last updated
- 8 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00100607
- Acronym / sponsor ID
- CAAE581A2203
- Conditions
- Osteoporosis
- Keywords
- osteoporosis/osteopenia, BMD, postmenopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 4 Jan 2005 (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.
This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMD T Score between -2 to -3.5
- 50-75 years old
Key exclusion criteria (3 listed)
- Urolithiasis
- Bisphosphonates
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| AAE581 | Drug | – |
Primary outcome
Lumbar spine BMD and total hip BMD after 1 year treatment
Safety and tolerability of one year treatment with different doses
4 secondary outcomes
Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
Effect of the different doses on markers for bone formation and bone resorption
Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
Histological information on bone biopsy after 12 months of treatment
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 8 May 2012.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AAE581 in people with Osteoporosis, run by Novartis Pharmaceuticals.
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 2 inclusion and 3 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 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lumbar spine BMD and total hip BMD after 1 year treatment. The study lists 2 primary outcomes in all. 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 8 May 2012.