Postmenopausal OsteoporosisPhase 3NCT02016716
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
A Phase 3 study testing Romosozumab 90 mg/mL and Romosozumab 70 mg/mL in people with Postmenopausal Osteoporosis, run by Amgen at 12 sites in 3 countries.
Trial summary
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Romosozumab 90 mg/mL and Romosozumab 70 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 3 Dec 2013to 8 Dec 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with osteoporosis at high risk for fracture defined as
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- a history of fragility fracture or at least 2 other risk factors
Who cannot join
- BMD T score < -3.50 at the total hip or femoral neck.
- History of hip fracture.
- History of metabolic or bone disease (except osteoporosis).
- Use of agents affecting bone metabolism.
- Vitamin D insufficiency.
- History of solid organ or bone marrow transplants.
Show all 9Show fewer
- Hyper- or hypocalcemia.
- Hyper- or hypothyroidism.
- Hyper- or hypoparathyroidism.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Poland7 sites
Research Site
Gdynia, 81-384
Research Site
Gliwice, 44-100
Research Site
Katowice, 40-040
Research Site
Krakow, 31-501
Research Site
Świdnik, 21-040
Research Site
Warsaw, 01-192
Research Site
Wroclaw, 50-088
Czechia3 sites
Research Site
Brno, 602 00
Research Site
Klatovy, 339 01
Research Site
Uherské Hradiště, 686 01
United States2 sites
Research Site
Bethesda, Maryland, 20817
Research Site
Gainesville, Georgia, 30501
About this study
Official title: A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
Read the detailed description
Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:
- Romosozumab 90 mg/mL
- Placebo 90 mg/mL
- Romosozumab 70 mg/mL
- Placebo 70 mg/mL
After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.
For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Romosozumab 90 mg/mL, Placebo 90 mg/mL, Romosozumab 70 mg/mL, Placebo 70 mg/mL
- Keywords
- Postmenopausal Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romosozumab 90 mg/mLDrug
Also called AMG 785, EVENITY™
Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
Placebo 90 mg/mLDrug
Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
Romosozumab 70 mg/mLDrug
Also called AMG 785, EVENITY™
Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
Placebo 70 mg/mLDrug
Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab 90 mg/mL | Experimental | Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months. Receives: Drug: Romosozumab 90 mg/mL |
| Placebo 90 mg/mL | Experimental | Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. Receives: Drug: Placebo 90 mg/mL |
| Romosozumab 70 mg/mL | Experimental | Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months. Receives: Drug: Romosozumab 70 mg/mL |
| Placebo 70 mg/mL | Placebo comparator | Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months. Receives: Drug: Placebo 70 mg/mL |
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 measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and month 6
Secondary outcomes (4)
Percent Change From Baseline in Total Hip BMD
Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.
Measured: Baseline and month 6
Percent Change From Baseline in Femoral Neck BMD
Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.
Measured: Baseline and month 6
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)
Measured: Baseline, month 1, month 3, and month 6
Percent Change From Baseline in Serum C-Telopeptide (CTX)
Measured: Baseline, month 1, month 3, and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start3 Dec 2013
- Primary completion8 Sep 2014
- Study completion8 Dec 2014
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016716
- Sponsor's protocol ID
- 20120156
- Other IDs
- 2013-000434-35
- Status last verified
- Sep 2018
- First submitted
- 10 Dec 2013
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT02016716
- Acronym / sponsor ID
- 20120156
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 8 Sep 2014 (actual)
- Study completion
- 8 Dec 2014 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 8 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
Detailed description
Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:
- Romosozumab 90 mg/mL
- Placebo 90 mg/mL
- Romosozumab 70 mg/mL
- Placebo 70 mg/mL
After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.
For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Romosozumab 90 mg/mL | Experimental | Drug: Romosozumab 90 mg/mLParticipants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months. |
| Placebo 90 mg/mL | Experimental | Drug: Placebo 90 mg/mLParticipants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. |
| Romosozumab 70 mg/mL | Experimental | Drug: Romosozumab 70 mg/mLParticipants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months. |
| Placebo 70 mg/mL | Placebo comparator | Drug: Placebo 70 mg/mLParticipants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women with osteoporosis at high risk for fracture defined as
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- a history of fragility fracture or at least 2 other risk factors
Key exclusion criteria (9 listed)
- BMD T score < -3.50 at the total hip or femoral neck.
- History of hip fracture.
- History of metabolic or bone disease (except osteoporosis).
- Use of agents affecting bone metabolism.
- Vitamin D insufficiency.
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 |
|---|---|---|
| Romosozumab 90 mg/mLAlso: AMG 785, EVENITY™Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS). | Drug | Romosozumab 90 mg/mL |
| Placebo 90 mg/mLPlacebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS. | Drug | Placebo 90 mg/mL |
| Romosozumab 70 mg/mLAlso: AMG 785, EVENITY™Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS. | Drug | Romosozumab 70 mg/mL |
| Placebo 70 mg/mLPlacebo administered as 3 SC injections with the 1.0 mL glass PFS. | Drug | Placebo 70 mg/mL |
Primary outcome
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
Time frame: Baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
4 secondary outcomes
Percent Change From Baseline in Total Hip BMD
Time frame: Baseline and month 6
Percent Change From Baseline in Femoral Neck BMD
Time frame: Baseline and month 6
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)
Time frame: Baseline, month 1, month 3, and month 6
Percent Change From Baseline in Serum C-Telopeptide (CTX)
Time frame: Baseline, month 1, month 3, and month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romosozumab 90 mg/mL and Romosozumab 70 mg/mL in people with Postmenopausal Osteoporosis, run by Amgen at 12 sites in 3 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 3 inclusion and 9 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland, Czechia, 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. 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 8 Nov 2018). 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 month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2018.