Postmenopausal OsteoporosisPhase 2NCT00293813
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
A Phase 2 study testing Alendronate and Denosumab in people with Postmenopausal Osteoporosis, run by Amgen.
Trial summary
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Alendronate and Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 2008
- Phase
- Phase 2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
- Must have low bone mineral density and meet specific eligibility criteria.
Who cannot join
- -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
About this study
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Alendronate, Denosumab, Placebo
- Keywords
- Post Menopausal, Osteoporosis, MicroCT, Amgen, denosumab, Extreme CT, XCT, Fosamax, Alendronate
- 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.
AlendronateDrug
Alendronate 70 mg PO QW
DenosumabDrug
denosumab 60 mg SC q 6 mos
PlaceboDrug
Placebo for alendronate and placebo for denosumab
| Study group | Role | What they receive |
|---|---|---|
| 3 | Placebo comparator | Placebo for denosumab and placebo for alendronate Receives: Drug: Placebo |
| 1 | Experimental | denosumab and placebo for alendronate Receives: Drug: Denosumab |
| 2 | Active comparator | Placebo for denosumab and alendronate Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
Cortical Thickness measured by XtremeCT.
Measured: 12 months
Secondary outcomes (1)
Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
Cortical Thickness measured by XtremeCT.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionAug 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293813
- Sponsor's protocol ID
- 20050179
- Status last verified
- Jul 2014
- First submitted
- 17 Feb 2006
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010 Aug;25(8):1886-94. doi: 10.1002/jbmr.81.
PubMed 20222106Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, Thomas T, Boutroy S, Bogado CE, Bilezikian JP, Seeman E. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014 Feb;59:173-9. doi: 10.1016/j.bone.2013.11.016. Epub 2013 Nov 22.
PubMed 24275677Hu YJ, Chines A, Shi Y, Seeman E, Guo XE. The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study. Bone. 2022 Jan;154:116187. doi: 10.1016/j.bone.2021.116187. Epub 2021 Sep 14.
PubMed 34530172
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT00293813
- Acronym / sponsor ID
- 20050179
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Post Menopausal, Osteoporosis, MicroCT, Amgen, denosumab, Extreme CT, XCT, Fosamax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Posted 27 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Placebo comparator | Drug: PlaceboPlacebo for denosumab and placebo for alendronate |
| 1 | Experimental | Drug: Denosumabdenosumab and placebo for alendronate |
| 2 | Active comparator | Drug: AlendronatePlacebo for denosumab and alendronate |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
- Must have low bone mineral density and meet specific eligibility criteria.
Key exclusion criteria (1 listed)
- -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
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 |
|---|---|---|
| AlendronateAlendronate 70 mg PO QW | Drug | 2 |
| Denosumabdenosumab 60 mg SC q 6 mos | Drug | 1 |
| PlaceboPlacebo for alendronate and placebo for denosumab | Drug | 3 |
Primary outcome
Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
Time frame: 12 months
Cortical Thickness measured by XtremeCT.
1 secondary outcome
Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20222106Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010 Aug;25(8):1886-94. doi: 10.1002/jbmr.81.
- Background: PubMed 24275677Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, Thomas T, Boutroy S, Bogado CE, Bilezikian JP, Seeman E. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014 Feb;59:173-9. doi: 10.1016/j.bone.2013.11.016. Epub 2013 Nov 22.
- Derived from this study: PubMed 34530172Hu YJ, Chines A, Shi Y, Seeman E, Guo XE. The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study. Bone. 2022 Jan;154:116187. doi: 10.1016/j.bone.2021.116187. Epub 2021 Sep 14.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alendronate and Denosumab in people with Postmenopausal Osteoporosis, run by Amgen.
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 1 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 25 Jul 2014. 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. 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 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?
Yes. Results are posted in the registry (first posted 27 Jan 2010). 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?
Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 (time frame: 12 months). 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 NCT00293813, which also lists 3 linked publications.
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 25 Jul 2014.