Postmenopausal OsteoporosisPhase 3NCT00091793
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
A Phase 3 study testing AMG 162 in people with Postmenopausal Osteoporosis, run by Amgen.
Trial summary
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population. Read more about this study
- Who is it for?
- Ages Up to 90 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- AMG 162
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Mar 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 Up to 90 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Eligibility Criteria
- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)
About this study
Official title: A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- AMG 162, Placebo
- Keywords
- Osteoporosis, Postmenopausal
- 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.
AMG 162Drug
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
PlaceboDrug
Placebo given at day 1, month 6, month 12 and month 18
| Study group | Role | What they receive |
|---|---|---|
| AMG 162 | Experimental | 60 mg/mL denosumab given day 1, month 6, month 12 and month 18 Receives: Drug: AMG 162 |
| Placebo | Placebo comparator | Placebo given day 1, month 6, month 12 and month 18 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 24 Months
Secondary outcomes (8)
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 24 Months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 24 Months
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 24 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 24 months
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 24 months
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Measured: 24 months
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Measured: 24 months
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2004 (estimated)
- Study startAug 2004
- Primary completionFeb 2009
- Study completionMar 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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091793
- Sponsor's protocol ID
- 20040132
- Status last verified
- Dec 2010
- First submitted
- 17 Sep 2004
- Last updated
- 31 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.
PubMed 18381571Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.
PubMed 19345291Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.
PubMed 21289258
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT00091793
- Acronym / sponsor ID
- 20040132
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Osteoporosis, Postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Sep 2004 (estimated)
- Results
- Posted 26 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 will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.
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 |
|---|---|---|
| AMG 162 | Experimental | Drug: AMG 16260 mg/mL denosumab given day 1, month 6, month 12 and month 18 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given day 1, month 6, month 12 and month 18 |
Who may qualify
- Ages
- Up to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| AMG 16260 mg/mL denosumab given day 1, month 6, month 12 and month 18 | Drug | AMG 162 |
| PlaceboPlacebo given at day 1, month 6, month 12 and month 18 | Drug | Placebo |
Primary outcome
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 Months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
8 secondary outcomes
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 Months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 Months
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 months
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 months
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 months
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 months
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18381571Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.
- Results publication: PubMed 19345291Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.
- Derived from this study: PubMed 21289258Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.
- 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 3 study testing AMG 162 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?
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 31 Dec 2010. 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 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 26 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?
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 (time frame: 24 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 NCT00091793, 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 31 Dec 2010.