Low Bone Mineral DensityPhase 3NCT00325468

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

A Phase 3 study testing AMG 162 in people with Low Bone Mineral Density, run by Amgen.

Completed

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

Trial summary

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Low Bone Mineral Density
What is being tested?: AMG 162
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: 1 May 2006to 2 Aug 2012
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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject must be ambulatory
Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
signed informed consent must be obtained before any study-specific procedures

Who cannot join

Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.

About this study

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Conditions: Low Bone Mineral Density
Being tested: AMG 162
Keywords: bone loss, osteoporosis
Medical subject headings: Bone Diseases, Metabolic, Osteoporosis

What participants receive

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

AMG 162Drug
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

Study groups in NCT00325468
Study group	Role	What they receive
AMG 162	Experimental	AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42 Receives: Drug: 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 Parent Study 20010223 Baseline to Year 8
Measured: 8 years
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
Measured: 8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
Measured: 8 years

Secondary outcomes (2)

Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
Measured: 8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
Measured: 8 years

Timeline

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

1 May 20062 Aug 2012

First posted12 May 2006 (estimated)
Study start1 May 2006
Primary completion28 Mar 2011
Study completion2 Aug 2012

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 Low Bone Mineral DensityStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00325468
Sponsor's protocol ID: 20050233
Status last verified: Jul 2017
First submitted: 10 May 2006
Last updated: 1 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.
PubMed 21159841

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

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All Low Bone Mineral Density trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
ClinicalTrials.gov ID: NCT00325468
Acronym / sponsor ID: 20050233
Conditions: Low Bone Mineral Density
Keywords: bone loss, osteoporosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 May 2006 (actual)
Primary completion: 28 Mar 2011 (actual)
Study completion: 2 Aug 2012 (actual)
First posted: 12 May 2006 (estimated)
Results: Posted 30 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AMG 162	Experimental	Drug: AMG 162AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Subject must be ambulatory
Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
signed informed consent must be obtained before any study-specific procedures

Key exclusion criteria (4 listed)

Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.

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 162AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42	Drug	AMG 162

Primary outcome

Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
Time frame: 8 years
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
Time frame: 8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
Time frame: 8 years

2 secondary outcomes

Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
Time frame: 8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
Time frame: 8 years

Results and safety

Results posted to the registry on 30 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	23	12
Denosumab 210 mg Q6M	17	12
Denosumab 30 mg Q3M	14	10
Denosumab Continuous Treatment	124	90
Alendronate 70mg QW	22	14

Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Time frame: 8 years. Least squares mean (95% Confidence Interval). Unit: percent

Measure	Placebo n = 12	Denosumab 210 mg Q6M n = 12	Denosumab 30 mg Q3M n = 8	Denosumab Continuous Treatment n = 88	Alendronate 70mg QW n = 13
Value	8.4 (4.4 to 12.4)	11.2 (7.2 to 15.2)	11.0 (6.0 to 16.0)	16.5 (14.9 to 18.1)	12.4 (8.5 to 16.4)

Population analysed: Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Primary outcome: Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Time frame: 8 years. Least squares mean (95% Confidence Interval). Unit: percent

Measure	Placebo n = 12	Denosumab 210 mg Q6M n = 12	Denosumab 30 mg Q3M n = 9	Denosumab Continuous Treatment n = 87	Alendronate 70mg QW n = 13
Value	1.1 (-1.2 to 3.5)	4.3 (2.0 to 6.6)	2.3 (-0.5 to 5.1)	6.8 (5.8 to 7.7)	3.4 (1.1 to 5.7)

Population analysed: Subjects with nonmissing value at parent study 20010223 baseline and Year 8

Primary outcome: Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Time frame: 8 years. Least squares mean (95% Confidence Interval). Unit: percent

Measure	Placebo n = 11	Denosumab 210 mg Q6M n = 10	Denosumab 30 mg Q3M n = 9	Denosumab Continuous Treatment n = 87	Alendronate 70mg QW n = 13
Value	-5.2 (-7.4 to -2.9)	1.4 (-0.9 to 3.8)	0.6 (-1.9 to 3.1)	1.3 (0.5 to 2.2)	-2.2 (-4.3 to -0.1)

Population analysed: Subjects with nonmissing value at parent study 20010223 baseline and Year 8

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 months (i.e., 4 years during the 20050233 extension study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 23 (13%)	18 of 23 (78.3%)	Not reported
Denosumab 210 mg Q6M	3 of 17 (17.6%)	15 of 17 (88.2%)	Not reported
Denosumab 30 mg Q3M	5 of 14 (35.7%)	13 of 14 (92.9%)	Not reported
Denosumab Continuous Treatment	31 of 124 (25%)	106 of 124 (85.5%)	Not reported
Alendronate 70 mg QW	3 of 22 (13.6%)	19 of 22 (86.4%)	Not reported
All Participants	45 of 200 (22.5%)	171 of 200 (85.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21159841Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Low Bone Mineral Density

Enrolling by invitation
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Tooth Loss, Dental Implant Failed
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Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
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Not yet recruiting
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RecruitingPhase 1
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Not yet recruitingObservational study
Comparing Lumbar Fusion With and Without Stress Endplate Augmentation in Patients With Low Bone Mass
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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 Low Bone Mineral Density, 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 3 inclusion and 4 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 1 Aug 2017. 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 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 30 Jul 2013). 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 Parent Study 20010223 Baseline to Year 8 (time frame: 8 years). The study lists 3 primary outcomes in all. 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 NCT00325468, 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 1 Aug 2017.