Postmenopausal OsteoporosisPhase 3NCT02157948
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
A Phase 3 study testing Denosumab (CP2) and Denosumab (CP4) in people with Postmenopausal Osteoporosis, run by Amgen at 23 sites in 4 countries.
Trial summary
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 100 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Denosumab (CP2) and Denosumab (CP4)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 23 sitesin 4 countries
- Study dates
- May 2014to Jul 2015
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to any study-specific activities/procedures
- Ambulatory postmenopausal women.
- Age 55 years or older
- Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.
Who cannot join
- Administration of osteoporosis treatments or bone active treatments within specific timeframes
- Vitamin D deficiency
- Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
- Contraindications to denosumab therapy (e.g., hypocalcemia)
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States10 sites
Research Site
Akron, Ohio, 44311
Research Site
Albuquerque, New Mexico, 87106
Research Site
Bend, Oregon, 97701
Research Site
Bethesda, Maryland, 20817
Research Site
Detroit, Michigan, 48236
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Gainesville, Georgia, 30501
Research Site
Lakewood, Colorado, 80227
Research Site
Santa Maria, California, 93454
Research Site
South Lake Tahoe, California, 96150
Poland7 sites
Research Site
Bialystok, 15-351
Research Site
Gliwice, 44-100
Research Site
Krakow, 31-501
Research Site
Lodz, 90-368
Research Site
Lodz, 90-558
Research Site
Świdnik, 21-040
Research Site
Warsaw, 04-730
Canada3 sites
Research Site
Québec, Quebec, G1V 3M7
Research Site
Vancouver, British Columbia, V5Z 4E1
Research Site
Westmout, Quebec, H3Z 1E5
Denmark3 sites
Research Site
Aalborg, 9000
Research Site
Ballerup Municipality, 2750
Research Site
Vejle, 7100
About this study
Official title: A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Denosumab (CP2), Denosumab (CP4)
- Keywords
- postmenopausal osteoporosis, osteoporosis, postmenopausal, denosumab, women
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab (CP2)Drug
Also called XGEVA®
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Denosumab (CP4)Drug
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab CP2 | Active comparator | Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. Receives: Drug: Denosumab (CP2) |
| Denosumab CP4 | Experimental | Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. Receives: Drug: Denosumab (CP4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lumbar Spine BMD
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 (2)
Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
Measured: Baseline, month 1, month 6 and month 12
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Measured: Baseline, month 1, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 394 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
- NCT02157948
- Sponsor's protocol ID
- 20120187
- Other IDs
- 2013-001279-19
- Status last verified
- Jul 2017
- First submitted
- 4 Jun 2014
- Last updated
- 16 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT02157948
- Acronym / sponsor ID
- 20120187
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- postmenopausal osteoporosis, osteoporosis, postmenopausal, denosumab, women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 16 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
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 |
|---|---|---|
| Denosumab CP2 | Active comparator | Drug: Denosumab (CP2)Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. |
| Denosumab CP4 | Experimental | Drug: Denosumab (CP4)Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has provided informed consent prior to any study-specific activities/procedures
- Ambulatory postmenopausal women.
- Age 55 years or older
- Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.
Key exclusion criteria (4 listed)
- Administration of osteoporosis treatments or bone active treatments within specific timeframes
- Vitamin D deficiency
- Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
- Contraindications to denosumab therapy (e.g., hypocalcemia)
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 |
|---|---|---|
| Denosumab (CP2)Also: XGEVA®Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe. | Drug | Denosumab CP2 |
| Denosumab (CP4)Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe. | Drug | Denosumab CP4 |
Primary outcome
Percent Change From Baseline in Lumbar Spine BMD
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.
2 secondary outcomes
Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
Time frame: Baseline, month 1, month 6 and month 12
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline, month 1, month 6 and month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- 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
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab (CP2) and Denosumab (CP4) in people with Postmenopausal Osteoporosis, run by Amgen at 23 sites in 4 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 4 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Poland, Canada, Denmark. 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 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 16 Aug 2017). 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 BMD (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?
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 16 Aug 2017.