Trial · NCT01652690
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
NCT01652690, Completed, Amgen; results first posted 2016-05-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice. Trials, record NCT01652690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01652690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
- NCT number
- NCT01652690
- Status
- Completed
- Enrollment
- 600 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Denosumab
- First posted
- 2012-07-30
- Last updated
- 2019-03-06
- Results first posted
- 2016-05-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office | 24 months | Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study. |
| Primary | Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively) | |
| Primary | Number of Participants Receiving All Prescriptions and Injections of Denosumab | Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively) | Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office. |
| Primary | Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care | 24 months | |
| Primary | Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection | Baseline (day 1) | Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection. |
| Primary | Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection | Month 6 | Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection. |
| Primary | Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection | Month 12 | Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection. |
| Primary | Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection | Month 18 | Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection. |
| Primary | Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection | Month 24 | Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection. |
| Primary | Number of Denosumab Post-baseline Injections Received by Each Participant | 24 months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office | 24 months | Full analysis set (all enrolled patients who provided informed consent and received at least one injection) | participants | NUMBER |
| PRIMARY | Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively) | Full analysis set; n = the number of participants who received the corresponding injection | participants | NUMBER |
| PRIMARY | Number of Participants Receiving All Prescriptions and Injections of Denosumab | Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively) | Full analysis set | participants | NUMBER |
| PRIMARY | Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care | 24 months | Full analysis set participants who discontinued the study prematurely | participants | NUMBER |
| PRIMARY | Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection | Baseline (day 1) | Full analysis set | participants | NUMBER |
| PRIMARY | Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection | Month 6 | Full analysis set participants who received a first post-baseline injection (i.e. at month 6) | participants | NUMBER |
| PRIMARY | Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection | Month 12 | Full analysis set participants who received a second post-baseline injection (i.e. at month 12) | participants | NUMBER |
| PRIMARY | Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection | Month 18 | Full analysis set participants who received a third post-baseline injection (i.e. at month 18) | participants | NUMBER |
| PRIMARY | Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection | Month 24 | Full analysis set participants who received a fourth post-baseline injection (i.e. at month 24) | participants | NUMBER |
| PRIMARY | Number of Denosumab Post-baseline Injections Received by Each Participant | 24 months | Full analysis set | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office | Czech Republic | 295 | participants | ||
| Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office | Slovakia | 296 | participants | ||
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Czech Republic | Baseline injection (n = 300, 300) | 300 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Slovakia | Baseline injection (n = 300, 300) | 298 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Czech Republic | First post-baseline injection (n = 283, 293) | 282 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Slovakia | First post-baseline injection (n = 283, 293) | 291 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Czech Republic | Second post-baseline injection (n = 276, 283) | 275 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Slovakia | Second post-baseline injection (n = 276, 283) | 282 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Czech Republic | Third post-baseline injection (n = 262, 276) | 260 | participants | |
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection | Slovakia | Third post-baseline injection (n = 262, 276) | 274 | participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Czech Republic | 300 | |
| Overall Study | STARTED | Slovakia | 300 | |
| Overall Study | COMPLETED | Czech Republic | 265 | |
| Overall Study | COMPLETED | Slovakia | 279 | |
| Overall Study | NOT COMPLETED | Czech Republic | 35 | |
| Overall Study | NOT COMPLETED | Slovakia | 21 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Myocardial infarction | Cardiac disorders | Czech Republic | 0 | 300 | |
| serious | Myocardial infarction | Cardiac disorders | Slovakia | 1 | 300 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Czech Republic | ||
| Total, all-cause mortality | Slovakia | ||
| Total, other adverse events | Czech Republic | 0 | 300 |
| Total, other adverse events | Slovakia | 0 | 300 |
| Total, serious adverse events | Czech Republic | 0 | 300 |
| Total, serious adverse events | Slovakia | 1 | 300 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30191465 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Czech Republic vs Slovakia: Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office | Trial comparisons |
| Czech Republic vs Slovakia: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01652690
GET https://conductscience.org/api/trials/v1/NCT01652690/results?page=2