OsteoporosisPhase 2NCT00306189

A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

A Phase 2 study testing 100 mg AMG 162, 60 mg AMG 162 and 14 mg AMG 162 in people with Osteoporosis, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12… Read more about this study

Who is it for?: Ages Up to 80 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: 100 mg AMG 162, 60 mg AMG 162 and 14 mg AMG 162
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 212 participants
Where: No sites listed yet
Study dates: Jan 2006to Nov 2007
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 Up to 80 years
Women only
No healthy volunteers
Child, Adult, Older adult

Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.

About this study

Official title: Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -

Conditions: Osteoporosis
Being tested: 100 mg AMG 162, 60 mg AMG 162, 14 mg AMG 162, Placebo
Keywords: RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, Japanese
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

100 mg AMG 162Drug
100 mg AMG 162 (denosumab) SC every 6 months
60 mg AMG 162Drug
60 mg AMG 162 (denosumab) SC every 6 months
14 mg AMG 162Drug
14 mg AMG 162 (denosumab) SC every 6 months
PlaceboDrug
Placebo SC every 6 months

Study groups in NCT00306189
Study group	Role	What they receive
100 mg AMG 162	Active comparator	Not described Receives: Drug: 100 mg AMG 162
60 mg AMG 162	Active comparator	Not described Receives: Drug: 60 mg AMG 162
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
14 mg AMG 162	Active comparator	Not described Receives: Drug: 14 mg AMG 162

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 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Nov 2007

First posted23 Mar 2006 (estimated)
Study startJan 2006
Primary completionJun 2007
Study completionNov 2007

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 (1)Papers the sponsor has linked to this study.
Other trials for 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 212 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00306189
Sponsor's protocol ID: 20050172
Other IDs: NOT APPRICABLE
Status last verified: Jun 2013
First submitted: 21 Mar 2006
Last updated: 20 Jun 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. Epub 2011 Sep 17.
PubMed 21927920

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
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Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
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Tumor Induced Osteomalcia, Osteomalacia
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A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia

All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -
ClinicalTrials.gov ID: NCT00306189
Acronym / sponsor ID: 20050172
Conditions: Osteoporosis
Keywords: RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, Japanese
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Jun 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 23 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
100 mg AMG 162	Active comparator	Drug: 100 mg AMG 162
60 mg AMG 162	Active comparator	Drug: 60 mg AMG 162
Placebo	Placebo comparator	Drug: Placebo
14 mg AMG 162	Active comparator	Drug: 14 mg AMG 162

Who may qualify

Ages: Up to 80 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
100 mg AMG 162100 mg AMG 162 (denosumab) SC every 6 months	Drug	100 mg AMG 162
60 mg AMG 16260 mg AMG 162 (denosumab) SC every 6 months	Drug	60 mg AMG 162
14 mg AMG 16214 mg AMG 162 (denosumab) SC every 6 months	Drug	14 mg AMG 162
PlaceboPlacebo SC every 6 months	Drug	Placebo

Primary outcome

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Time frame: 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Results and safety

Results posted to the registry on 27 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Denosumab 14 mg Q6M	57	48
Denosumab 60 mg Q6M	56	50
Denosumab 100 mg Q6M	56	45
Placebo	57	52

Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Time frame: 12 months. Mean (95% Confidence Interval). Unit: Percent Change from Baseline

Measure	Placebo n = 55	Denosumab 14 mg Q6M n = 53	Denosumab 60 mg Q6M n = 54	Denosumab 100 mg Q6M n = 50
Value	.46 (-.23 to 1.15)	5.71 (4.76 to 6.65)	6.73 (5.71 to 7.75)	7.45 (6.38 to 8.53)

Placebo vs Denosumab 100 mg Q6M: Mean Difference (Final Values): 7 (95% CI 5.76 to 8.24), p <0.0001, t-test, 2 sided
Placebo vs Denosumab 14 mg Q6M: Mean Difference (Final Values): 5.25 (95% CI 4.1 to 6.4), p <0.0001, t-test, 2 sided
Placebo vs Denosumab 60 mg Q6M: Mean Difference (Final Values): 6.27 (95% CI 5.06 to 7.49), p <0.0001, t-test, 2 sided

Population analysed: All subjects who received \>= 1 dose of investigational product and have a baseline and \>= 1 post baseline measurement at the lumbar spine.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 54 (7.4%)	49 of 54 (90.7%)	Not reported
Denosumab 14 mg Q6M	6 of 53 (11.3%)	50 of 53 (94.3%)	Not reported
Denosumab 60 mg Q6M	4 of 54 (7.4%)	47 of 54 (87%)	Not reported
Denosumab 100 mg Q6M	2 of 51 (3.9%)	48 of 51 (94.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21927920Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. Epub 2011 Sep 17.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Osteoporosis

Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia

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 100 mg AMG 162, 60 mg AMG 162 and 14 mg AMG 162 in people with 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 20 Jun 2013. 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?

Lumbar Spine Bone Mineral Density 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 NCT00306189, which also lists 1 linked publication.

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 20 Jun 2013.