Osteoporosis in MenPhase 3BRIDGENCT02186171

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

A Phase 3 study testing Romosozumab in people with Osteoporosis in Men, run by Amgen at 34 sites in 10 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 55 to 90 years, men only
Conditions the study is for: Osteoporosis in Men
What is being tested?: Romosozumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 245 participants
Where: 34 sitesin 10 countries
Study dates: 16 Jun 2014to 20 Apr 2016
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 55 to 90 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

Who cannot join

A BMD T score ≤ -3.50 at the hip,
History of hip fracture
Severe metabolic bone diseases
Significant laboratory abnormalities
Recent treatment with agents affecting bone metabolism

Trial locations and contacts

34 sites in 10 countries.

Country

City, postcode or hospital

34 sites in 10 countries

Japan7 sites

Research Site
Bungoono-shi, Oita Prefecture, 879-7125
Research Site
Hachioji-shi, Tokyo, 192-0046
Research Site
Mizunami-shi, Gifu, 509-6134
Research Site
Shinagawa-ku, Tokyo, 140-0011
Research Site
Takatsuki-shi, Osaka, 569-1123
Research Site
Toshima-ku, Tokyo, 171-0033
Research Site
Yokohama, Kanagawa, 223-0062

Other trials in Japan

Belgium4 sites

Research Site
Genk, 3600
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4020

Other trials in Belgium

Poland4 sites

Research Site
Lodz, 90-558
Research Site
Świdnik, 21-040
Research Site
Warsaw, 01-192
Research Site
Wroclaw, 50-088

Other trials in Poland

United States3 sites

Research Site
Albuquerque, New Mexico, 87106
Research Site
Bethesda, Maryland, 20817
Research Site
Lakewood, Colorado, 80227

Other trials in United States

Czechia3 sites

Research Site
Ostrava-Trebovice, 722 00
Research Site
Pilsen, 305 99
Research Site
Praha 11 - Chodov, 148 00

Other trials in Czechia

Mexico3 sites

Research Site
Culiacán, Sinaloa, 80000
Research Site
Mexicali, Baja California Norte, 21100
Research Site
Monterrey, Nuevo León, 64460

Other trials in Mexico

Russia3 sites

Research Site
Moscow, 101990
Research Site
Saint Petersburg, 190103
Research Site
Yaroslavl, 150003

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Switzerland3 sites

Research Site
Bern, 3010
Research Site
Zurich, 8063
Research Site
Zurich, 8091

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Colombia2 sites

Research Site
Bogota, Cundinamarca, 11001000
Research Site
Medellín, Antioquia, 050021

Other trials in Colombia

Denmark2 sites

Research Site
Aalborg, 9000
Research Site
Ballerup Municipality, 2750

Other trials in Denmark

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis

The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.

Conditions: Osteoporosis in Men
Being tested: Romosozumab, Placebo
Keywords: Osteoporosis in men

What participants receive

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

RomosozumabBiological
Also called AMG 785, EVENITY™
Administered by subcutaneous injection once a month.
PlaceboDrug
Administered by subcutaneous injection once a month.

Study groups in NCT02186171
Study group	Role	What they receive
Romosozumab	Experimental	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. Receives: Biological: Romosozumab
Placebo	Placebo comparator	Participants received placebo subcutaneous injections once a month for 12 months. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 12

Secondary outcomes (5)

Percent Change From Baseline in BMD at the Total Hip at Month 12
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 12
Percent Change From Baseline in BMD at the Femoral Neck at Month 12
Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 6
Percent Change From Baseline in BMD at the Total Hip at Month 6
Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 6
Percent Change From Baseline in BMD at the Femoral Neck at Month 6
Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 6

Timeline

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

16 Jun 201420 Apr 2016

First posted10 Jul 2014 (estimated)
Study start16 Jun 2014
Primary completion15 Feb 2016
Study completion20 Apr 2016

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 Osteoporosis in MenStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02186171
Sponsor's protocol ID: 20110174
Other IDs: 2013-005551-32
Acronym: BRIDGE
Status last verified: May 2019
First submitted: 23 Jun 2014
Last updated: 28 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.
PubMed 29931216

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?

See locations

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Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Healthy, Osteopenia
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Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis
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OST and MORES in Male Osteoporosis
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All Osteoporosis in Men trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
ClinicalTrials.gov ID: NCT02186171
Acronym / sponsor ID: BRIDGE / 20110174
Conditions: Osteoporosis in Men
Keywords: Osteoporosis in men
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 16 Jun 2014 (actual)
Primary completion: 15 Feb 2016 (actual)
Study completion: 20 Apr 2016 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 28 May 2019

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: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Romosozumab	Experimental	Biological: RomosozumabParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo subcutaneous injections once a month for 12 months.

Who may qualify

Ages: 55 to 90 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

Key exclusion criteria (5 listed)

A BMD T score ≤ -3.50 at the hip,
History of hip fracture
Severe metabolic bone diseases
Significant laboratory abnormalities
Recent treatment with agents affecting bone metabolism

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
RomosozumabAlso: AMG 785, EVENITY™Administered by subcutaneous injection once a month.	Biological	Romosozumab
PlaceboAdministered by subcutaneous injection once a month.	Drug	Placebo

Primary outcome

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
Time frame: Baseline and month 12
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

5 secondary outcomes

Percent Change From Baseline in BMD at the Total Hip at Month 12
Time frame: Baseline and month 12
Percent Change From Baseline in BMD at the Femoral Neck at Month 12
Time frame: Baseline and month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time frame: Baseline and month 6
Percent Change From Baseline in BMD at the Total Hip at Month 6
Time frame: Baseline and month 6
Percent Change From Baseline in BMD at the Femoral Neck at Month 6
Time frame: Baseline and month 6

Results and safety

Results posted to the registry on 28 May 2019, 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	82	78
Romosozumab 210 mg	163	148

Primary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12

Time frame: Baseline and month 12. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo n = 79	Romosozumab 210 mg n = 157
Value	1.2 (0.5)	12.1 (0.5)

Placebo vs Romosozumab 210 mg: LS Mean Difference: 10.9 (95% CI 9.6 to 12.2), p < 0.0001, ANCOVA

Population analysed: Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	10 of 81 (12.3%)	41 of 81 (50.6%)	Not reported
Romosozumab 210 mg	23 of 163 (14.1%)	74 of 163 (45.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29931216Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Osteoporosis in Men

Active, not recruiting
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Healthy, Osteopenia
Active, not recruitingObservational study
Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis
Osteoporosis
Active, not recruitingObservational study
OST and MORES in Male Osteoporosis
Male Osteoporosis
Not yet recruiting
The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes.
Osteoporosis, Accidental Falls

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

34 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Romosozumab in people with Osteoporosis in Men, run by Amgen at 34 sites in 10 countries.

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 5 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Japan, Belgium, Poland, United States, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 28 May 2019). 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?

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 (time frame: Baseline and month 12). 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 NCT02186171, 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 28 May 2019.