Osteoporosis, Age-RelatedNCT02732210
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
An observational study of Osteoporosis, Age-Related, run by Amgen at 89 sites in 2 countries.
Trial summary
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis, Age-Related
- How many people
- 935 participants
- Where
- 89 sitesin 2 countries
- Study dates
- 6 Jul 2011to 14 Apr 2014
- Phase
- Observational
- 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
Study population: Postmenoapusal women with osteoporsis. Sampling method is Invitation to Volunteer.
Who may be able to join
- Enrollment within 4 weeks following administration of the first Prolia® (denosumab 60 mg) injection
- Received Prolia® subcutaneously for treatment of osteoporosis consistent with local (US/Canada) product label
- Subject or subject's legally acceptable representative has provided informed consent. Exclusion Criteria:
- Participation in ongoing or previous denosumab clinical trials
- Currently enrolled in another investigational device or drug study, or less than 6 months since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- Contra-indicated for treatment with Prolia® according to the approved applicable local product label (US/Canada)
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
Who cannot join
None listed.
Trial locations and contacts
89 sites in 2 countries.
89 sites in 2 countries
United States60 sites
Research Site
Akron, Ohio, 44313
Research Site
Albuquerque, New Mexico, 87106
Research Site
Alton, Illinois, 62002
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Asheboro, North Carolina, 27203
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Atlanta, Georgia, 30342
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Austin, Texas, 78731
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Bend, Oregon, 97701
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Bettendorf, Iowa, 52722
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Birmingham, Alabama, 35205
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Brooklyn, New York, 11201
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Butler, New Jersey, 07405
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Centerville, Ohio, 45459
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Chandler, Arizona, 85224
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Charleston, West Virginia, 25304
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Charlotte, North Carolina, 28210
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Chesapeake, Virginia, 23321
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Cincinnati, Ohio, 45236
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Detroit, Michigan, 48236
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Dover, New Jersey, 07801
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Duncansville, Pennsylvania, 16635
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East Lansing, Michigan, 48823
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Fort Myers, Florida, 33912
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Gainesville, Georgia, 30501
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Glendale, Wisconsin, 53217
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Hemet, California, 92543
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Hollywood, Florida, 33021
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32258
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Kissimmee, Florida, 34741
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Laguna Hills, California, 92653
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Lakewood, Colorado, 80227
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Lansdale, Pennsylvania, 19446
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Lansing, Michigan, 48910
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Las Vegas, Nevada, 89146
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Los Angeles, California, 90048
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Madison, Wisconsin, 53705
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Middletown, Ohio, 45044
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Midlothian, Virginia, 23114
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Murrieta, California, 92563
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Myrtle Beach, South Carolina, 29572
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Oxnard, California, 93030
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Pembroke Pines, Florida, 33028
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Peoria, Arizona, 85381
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Phoenix, Arizona, 85050
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Plainview, New York, 11803
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Rockford, Illinois, 61103
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Santa Maria, California, 93454
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Santa Monica, California, 90404
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Sebring, Florida, 33870
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South Lake Tahoe, California, 96150
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Southlake, Texas, 76092
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Spokane, Washington, 99204
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Springfield, Missouri, 65807
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Tabor City, North Carolina, 28463
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Trumbull, Connecticut, 06611
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Victorville, California, 92395
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Winchester, Virginia, 22601
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Winston-Salem, North Carolina, 27103
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Woodbury, Minnesota, 55125
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Woodstock, Georgia, 30189
Canada29 sites
Research Site
Brampton, Ontario, L6T 0G1
Research Site
Calgary, Alberta, T2X 3X7
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Corunna, Ontario, N0N 1G0
Research Site
Halifax, Nova Scotia, B3H 2Y9
Research Site
London, Ontario, N5W 6A2
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London, Ontario, N6A 5G6
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Montreal, Quebec, H2L 1S6
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Montreal, Quebec, H3T 1E2
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Newmarket, Ontario, L3Y 5G8
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Oakville, Ontario, L6J 1X8
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Peterborough, Ontario, K9H 2P4
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Pointe-Claire, Quebec, H9R 3J1
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Pointe-Claire, Quebec, H9R 4S3
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Québec, Quebec, G1V 3M7
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Saint-Jean-sur-Richelieu, Quebec, J2W 1J1
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Sarnia, Ontario, N7T 4X3
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Saskatoon, Saskatchewan, S7K 0H6
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8
Research Site
St. John's, Newfoundland and Labrador, A1E 2E2
Research Site
Toronto, Ontario, M3M 3E5
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Toronto, Ontario, M4S 1Y2
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Trois-Rivières, Quebec, G8Z 1Y2
Research Site
Vancouver, British Columbia, V5Z 4E1
Research Site
Victora, British Columbia, V9A 7N6
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Westmount, Quebec, H3Z 2P9
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Westmout, Quebec, H3Z 1E5
Research Site
Winnipeg, Manitoba, R3A 1M3
Research Site
Winnipeg, Manitoba, R3T 2E8
Research Site
Woodstock, Ontario, N4S 5P5
About this study
Official title: Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
Read the detailed description
The study was a multi-center, single-arm, prospective, non-interventional observational study in postmenopausal women with osteoporosis who had been treated with Prolia® for osteoporosis in routine clinical practice.
- Conditions
- Osteoporosis, Age-Related
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Persistence With Prolia® at 12 Ponths
A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.
Measured: 12 months
Percentage of Participants With Persistence With Prolia® at 24 Months
A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).
Measured: 24 months
Secondary outcomes (4)
Time to Non-persistence
For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).
Measured: 24 months
Number of Prolia® Injections Received
The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.
Measured: 24 months
Percentage of Participants Satisfying Medication-taking Behavior at 12 Months
Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.
Measured: 12 months
Percentage of Participants Satisfying Medication-taking Behavior at 24 Months
Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start6 Jul 2011
- Primary completion7 Apr 2014
- Study completion14 Apr 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, Age-RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 935 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
- NCT02732210
- Sponsor's protocol ID
- 20101218
- Status last verified
- Nov 2022
- First submitted
- 4 Apr 2016
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Silverman SL, Siris E, Kendler DL, Belazi D, Brown JP, Gold DT, Lewiecki EM, Papaioannou A, Simonelli C, Ferreira I, Balasubramanian A, Dakin P, Ho P, Siddhanti S, Stolshek B, Recknor C. Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study. Osteoporos Int. 2015 Jan;26(1):361-72. doi: 10.1007/s00198-014-2871-6. Epub 2014 Sep 19.
PubMed 25236877Silverman SL, Siris E, Belazi D, Recknor C, Papaioannou A, Brown JP, Gold DT, Lewiecki EM, Quinn G, Balasubramanian A, Yue S, Stolshek B, Kendler DL. Persistence at 24 months with denosumab among postmenopausal women with osteoporosis: results of a prospective cohort study. Arch Osteoporos. 2018 Aug 7;13(1):85. doi: 10.1007/s11657-018-0491-z.
PubMed 30088189
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02732210
- Acronym / sponsor ID
- 20101218
- Conditions
- Osteoporosis, Age-Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 935 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- 7 Apr 2014 (actual)
- Study completion
- 14 Apr 2014 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
Detailed description
The study was a multi-center, single-arm, prospective, non-interventional observational study in postmenopausal women with osteoporosis who had been treated with Prolia® for osteoporosis in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenoapusal women with osteoporsis. Sampling method is Invitation to Volunteer.
Key inclusion criteria (7 listed)
- Enrollment within 4 weeks following administration of the first Prolia® (denosumab 60 mg) injection
- Received Prolia® subcutaneously for treatment of osteoporosis consistent with local (US/Canada) product label
- Subject or subject's legally acceptable representative has provided informed consent. Exclusion Criteria:
- Participation in ongoing or previous denosumab clinical trials
- Currently enrolled in another investigational device or drug study, or less than 6 months since ending another investigational device or drug study(s), or receiving other investigational agent(s)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Persistence With Prolia® at 12 Ponths
Time frame: 12 months
A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.
Percentage of Participants With Persistence With Prolia® at 24 Months
Time frame: 24 months
A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).
4 secondary outcomes
Time to Non-persistence
Time frame: 24 months
Number of Prolia® Injections Received
Time frame: 24 months
Percentage of Participants Satisfying Medication-taking Behavior at 12 Months
Time frame: 12 months
Percentage of Participants Satisfying Medication-taking Behavior at 24 Months
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25236877Silverman SL, Siris E, Kendler DL, Belazi D, Brown JP, Gold DT, Lewiecki EM, Papaioannou A, Simonelli C, Ferreira I, Balasubramanian A, Dakin P, Ho P, Siddhanti S, Stolshek B, Recknor C. Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study. Osteoporos Int. 2015 Jan;26(1):361-72. doi: 10.1007/s00198-014-2871-6. Epub 2014 Sep 19.
- Background: PubMed 30088189Silverman SL, Siris E, Belazi D, Recknor C, Papaioannou A, Brown JP, Gold DT, Lewiecki EM, Quinn G, Balasubramanian A, Yue S, Stolshek B, Kendler DL. Persistence at 24 months with denosumab among postmenopausal women with osteoporosis: results of a prospective cohort study. Arch Osteoporos. 2018 Aug 7;13(1):85. doi: 10.1007/s11657-018-0491-z.
- 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
89 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Age-Related, run by Amgen at 89 sites in 2 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 7 inclusion and 0 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Canada. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2016). 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?
Percentage of Participants With Persistence With Prolia® at 12 Ponths (time frame: 12 months). The study lists 2 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 NCT02732210, which also lists 2 linked publications.
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 29 Nov 2022.