Osteoporosis, Age-Related
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Persistence With Prolia® at 12 Ponths | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Non-persistence | 24 months | 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). |
| Number of Prolia® Injections Received | 24 months | The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received. |
| Percentage of Participants Satisfying Medication-taking Behavior at 12 Months | 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. |
| Percentage of Participants Satisfying Medication-taking Behavior at 24 Months | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
The first participant was enrolled into the study on 6 July 2011 and enrollment continued until the 935th participant enrolled on the 5 April 2012. All participants were to be observed for at least 2 years, the last subjects last reported end date was 14 April 2014.
Participants by arm
| Arm | Count |
|---|---|
| Canada Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada. | 303 |
| United States Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States. | 632 |
| Total | 935 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 15 |
| Overall Study | Lost to Follow-up | 5 | 57 |
| Overall Study | Missing | 0 | 8 |
| Overall Study | Other | 35 | 103 |
| Overall Study | Site Closed | 0 | 11 |
| Overall Study | Study Ended | 13 | 13 |
| Overall Study | Withdrawal by Subject | 28 | 87 |
Baseline characteristics
| Characteristic | Total | Canada | United States |
|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 9.9 | 68.6 years STANDARD_DEVIATION 9.2 | 71.9 years STANDARD_DEVIATION 10 |
| Age, Customized ≥ 65 to < 75 years | 318 participants | 102 participants | 216 participants |
| Age, Customized < 65 years | 267 participants | 115 participants | 152 participants |
| Age, Customized ≥ 75 years | 350 participants | 86 participants | 264 participants |
| Ethnicity Hispanic or Latino | 47 participants | 2 participants | 45 participants |
| Ethnicity Not Hispanic or Latino | 888 participants | 301 participants | 587 participants |
| Race American Indian or Alaska Native | 2 participants | 0 participants | 2 participants |
| Race Asian | 25 participants | 16 participants | 9 participants |
| Race Black or African American | 9 participants | 0 participants | 9 participants |
| Race Mixed race | 2 participants | 0 participants | 2 participants |
| Race Native Hawaiian or Other Pacific Islander | 2 participants | 1 participants | 1 participants |
| Race Other | 9 participants | 1 participants | 8 participants |
| Race White | 886 participants | 285 participants | 601 participants |
| Sex: Female, Male Female | 935 Participants | 303 Participants | 632 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 303 | 0 / 632 |
| serious Total, serious adverse events | 27 / 303 | 95 / 632 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Full Analysis Set (all enrolled participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canada | Percentage of Participants With Persistence With Prolia® at 12 Ponths | 87.8 percentage of participants |
| United States | Percentage of Participants With Persistence With Prolia® at 12 Ponths | 81.0 percentage of participants |
Primary
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).
Time frame: 24 months
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canada | Percentage of Participants With Persistence With Prolia® at 24 Months | 74.9 percentage of participants |
| United States | Percentage of Participants With Persistence With Prolia® at 24 Months | 50.0 percentage of participants |
Secondary
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.
Time frame: 24 months
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Canada | Number of Prolia® Injections Received | 5.0 prolia injections |
| United States | Number of Prolia® Injections Received | 4.0 prolia injections |
Secondary
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.
Time frame: 12 months
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canada | Percentage of Participants Satisfying Medication-taking Behavior at 12 Months | 82.2 percentage of participants |
| United States | Percentage of Participants Satisfying Medication-taking Behavior at 12 Months | 72.0 percentage of participants |
Secondary
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.
Time frame: 24 months
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canada | Percentage of Participants Satisfying Medication-taking Behavior at 24 Months | 62.7 percentage of participants |
| United States | Percentage of Participants Satisfying Medication-taking Behavior at 24 Months | 36.4 percentage of participants |
Secondary
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).
Time frame: 24 months
Population: Full analysis set with non-persistence at 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Canada | Time to Non-persistence | 10.69 months |
| United States | Time to Non-persistence | 12.14 months |