OsteoporosisPhase 1NCT01588509

Transition From Alendronate to Romosozumab (AMG 785)

A Phase 1 study testing Romosozumab in people with Osteoporosis, run by Amgen at 9 sites in United States.

Completed

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

Trial summary

The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate. Read more about this study

Who is it for?: Ages 55 to 85 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: Romosozumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 9 sitesUnited States
Study dates: 30 Mar 2012to 21 Nov 2012
Phase: Phase 1
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 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance

Who cannot join

History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Research Site
Albuquerque, New Mexico, 87106
Research Site
Bethesda, Maryland, 20817
Research Site
Gainesville, Georgia, 30501
Research Site
Honolulu, Hawaii, 96813
Research Site
Seattle, Washington, 98144
Research Site
Tucson, Arizona, 85711
Research Site
Walnut Creek, California, 94598
Research Site
West Haverstraw, New York, 10993
Research Site
Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate

Conditions: Osteoporosis
Being tested: Romosozumab
Keywords: AMG 785, bone mineral density, alendronate
Medical subject headings: Osteoporosis

What participants receive

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

RomosozumabDrug
Also called AMG 785, EVENITY™
Administered by subcutaneous injection

Study groups in NCT01588509
Study group	Role	What they receive
Romosozumab 140 mg	Experimental	Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months. Receives: Drug: Romosozumab
Romosozumab 210 mg	Experimental	Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months. Receives: Drug: Romosozumab

What is being measured

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

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.
Measured: Baseline and day 85

Secondary outcomes (7)

Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
Measured: Baseline and day 85
Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
Measured: Baseline and day 85
Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)
Measured: Baseline and days 4, 15, 29, 43, 57, 71, and 85
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Measured: Baseline and days 4, 15, 29, 43, 57, 71, and 85
Number of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant.
Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.
A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product?
A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria:
- fatal,
- life-threatening,
- required in-patient hospitalization or prolongation of existing hospitalization,
- resulted in persistent or significant disability/incapacity,
- congenital anomaly/birth defect, and/or
- other medically important serious event.
Measured: From first dose of study drug up to day 85
Number of Participants Who Developed Anti-romosozumab Antibodies
Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline.
Measured: Baseline and days 29, 57, and 85
Mean Serum Concentration of Romosozumab
Measured: Days 4, 15, 29, 43, 57, 71 and 85

Timeline

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

30 Mar 201221 Nov 2012

First posted1 May 2012 (estimated)
Study start30 Mar 2012
Primary completion21 Nov 2012
Study completion21 Nov 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.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588509
Sponsor's protocol ID: 20110253
Status last verified: Mar 2019
First submitted: 17 Apr 2012
Last updated: 26 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate
ClinicalTrials.gov ID: NCT01588509
Acronym / sponsor ID: 20110253
Conditions: Osteoporosis
Keywords: AMG 785, bone mineral density, alendronate
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 30 Mar 2012 (actual)
Primary completion: 21 Nov 2012 (actual)
Study completion: 21 Nov 2012 (actual)
First posted: 1 May 2012 (estimated)
Results: Posted 4 Mar 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: None (open label)
Number of arms: 2

Arm	Type	Receives
Romosozumab 140 mg	Experimental	Drug: RomosozumabParticipants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
Romosozumab 210 mg	Experimental	Drug: RomosozumabParticipants received romosozumab 210 mg administered subcutaneously once a month for 3 months.

Who may qualify

Ages: 55 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance

Key exclusion criteria (3 listed)

History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)

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	Drug	Romosozumab 140 mg, Romosozumab 210 mg

Primary outcome

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
Time frame: Baseline and day 85
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.

7 secondary outcomes

Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck
Time frame: Baseline and day 85
Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip
Time frame: Baseline and day 85
Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)
Time frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Time frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85
Number of Participants With Adverse Events
Time frame: From first dose of study drug up to day 85
Number of Participants Who Developed Anti-romosozumab Antibodies
Time frame: Baseline and days 29, 57, and 85
Mean Serum Concentration of Romosozumab
Time frame: Days 4, 15, 29, 43, 57, 71 and 85

Results and safety

Results posted to the registry on 4 Mar 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
Romosozumab 140 mg	30	29
Romosozumab 210 mg	30	30

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

Time frame: Baseline and day 85. Mean (Standard Error). Unit: percent change

Measure	Romosozumab 140 mg n = 29	Romosozumab 210 mg n = 30
Value	2.13 (0.64)	2.08 (0.63)

Romosozumab 140 mg: Percent Change from Baseline: 2.13 (90% CI 1.05 to 3.20), p = 0.002, ANOVA
Romosozumab 210 mg: Percent Change from Baseline: 2.08 (90% CI 1.02 to 3.14), p = 0.002, ANOVA

Population analysed: All participants who received study drug and with non-missing baseline and day 85 measurements.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to day 85. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Romosozumab 140 mg	0 of 30 (0%)	11 of 30 (36.7%)	Not reported
Romosozumab 210 mg	0 of 30 (0%)	6 of 30 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
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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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Romosozumab in people with Osteoporosis, run by Amgen at 9 sites in United States.

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 3 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 4 Mar 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 Bone Mineral Density (BMD) at the Lumbar Spine (time frame: Baseline and day 85). 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 NCT01588509.

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 26 Mar 2019.