Trial Outcomes & Findings for Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice (NCT NCT01652690)

NCT ID: NCT01652690

Last Updated: 2019-03-06

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 600 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2019-03-06

Participant Flow

The study was conducted at various study centers in the Czech Republic and Slovakia. The recruitment period was from 26 June 2012 to 15 May 2013.

Participant milestones

Measure	Czech Republic Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Overall Study STARTED	300	300
Overall Study COMPLETED	265	279
Overall Study NOT COMPLETED	35	21

Reasons for withdrawal

Measure	Czech Republic Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Overall Study Withdrawal by Subject	16	4
Overall Study Other	8	9
Overall Study Lost to Follow-up	6	6
Overall Study Death	5	2

Baseline Characteristics

Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

Baseline characteristics by cohort

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Total n=600 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 8.7 • n=5 Participants	64.3 years STANDARD_DEVIATION 8.6 • n=7 Participants	66.7 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	300 Participants n=5 Participants	300 Participants n=7 Participants	600 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age at Menopause	48.3 years STANDARD_DEVIATION 5.6 • n=5 Participants	48.3 years STANDARD_DEVIATION 5.2 • n=7 Participants	48.3 years STANDARD_DEVIATION 5.4 • n=5 Participants
Time Since Postmenopausal Osteoarthritis Diagnosis	5.3 years STANDARD_DEVIATION 5.2 • n=5 Participants	3.0 years STANDARD_DEVIATION 4.1 • n=7 Participants	4.1 years STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Full analysis set (all enrolled patients who provided informed consent and received at least one injection)

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.

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office	295 participants	296 participants

PRIMARY outcome

Timeframe: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Population: Full analysis set; n = the number of participants who received the corresponding injection

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection Baseline injection (n = 300, 300)	300 participants	298 participants
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection First post-baseline injection (n = 283, 293)	282 participants	291 participants
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection Second post-baseline injection (n = 276, 283)	275 participants	282 participants
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection Third post-baseline injection (n = 262, 276)	260 participants	274 participants
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection Fourth post-baseline injection (n = 246, 243)	245 participants	240 participants

PRIMARY outcome

Timeframe: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Population: Full analysis set

Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants Receiving All Prescriptions and Injections of Denosumab First post-baseline injection	283 participants	293 participants
Number of Participants Receiving All Prescriptions and Injections of Denosumab Second post-baseline injection	276 participants	283 participants
Number of Participants Receiving All Prescriptions and Injections of Denosumab Third post-baseline injection	262 participants	276 participants
Number of Participants Receiving All Prescriptions and Injections of Denosumab Fourth post-baseline injection	246 participants	243 participants

PRIMARY outcome

Timeframe: 24 months

Population: Full analysis set participants who discontinued the study prematurely

Outcome measures

Measure	Czech Republic n=35 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=21 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care Referred to other health care providers (total)	0 participants	2 participants
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care Referred to rheumatologist	0 participants	2 participants

PRIMARY outcome

Timeframe: Baseline (day 1)

Population: Full analysis set

Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection Prescribing Physician	54 participants	84 participants
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection Other Physician	19 participants	21 participants
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection Nurse	227 participants	195 participants

PRIMARY outcome

Timeframe: Month 6

Population: Full analysis set participants who received a first post-baseline injection (i.e. at 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.

Outcome measures

Measure	Czech Republic n=283 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=293 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection Prescribing Physician	70 participants	109 participants
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection Other Physician	8 participants	0 participants
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection Nurse	205 participants	184 participants

PRIMARY outcome

Timeframe: Month 12

Population: Full analysis set participants who received a second post-baseline injection (i.e. at 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.

Outcome measures

Measure	Czech Republic n=276 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=283 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection Prescribing Physician	75 participants	104 participants
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection Other Physician	0 participants	0 participants
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection Nurse	201 participants	179 participants

PRIMARY outcome

Timeframe: Month 18

Population: Full analysis set participants who received a third post-baseline injection (i.e. at 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.

Outcome measures

Measure	Czech Republic n=262 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=276 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection Prescribing Physician	69 participants	113 participants
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection Other Physician	4 participants	1 participants
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection Nurse	189 participants	162 participants

PRIMARY outcome

Timeframe: Month 24

Population: Full analysis set participants who received a fourth post-baseline injection (i.e. at 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.

Outcome measures

Measure	Czech Republic n=246 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=243 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection Prescribing Physician	76 participants	93 participants
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection Other Physician	0 participants	6 participants
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection Nurse	170 participants	144 participants

PRIMARY outcome

Timeframe: 24 months

Population: Full analysis set

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Denosumab Post-baseline Injections Received by Each Participant One post-baseline injection	7 participants	10 participants
Number of Denosumab Post-baseline Injections Received by Each Participant No post-baseline injections	17 participants	7 participants
Number of Denosumab Post-baseline Injections Received by Each Participant Two post-baseline injections	14 participants	7 participants
Number of Denosumab Post-baseline Injections Received by Each Participant Three post-baseline injections	16 participants	33 participants
Number of Denosumab Post-baseline Injections Received by Each Participant Four post-baseline injections	246 participants	243 participants

PRIMARY outcome

Timeframe: Pre-baseline (before first denosumab injection) and during the study (post-baseline)

Population: Full analysis set

Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants Having Radiologic Bone Assessments Pre-baseline	297 participants	299 participants
Number of Participants Having Radiologic Bone Assessments Post-baseline	253 participants	216 participants

PRIMARY outcome

Timeframe: Pre-baseline (before first denosumab injection) and post-baseline

Population: Full analysis set; n = participants with visits at each time point.

Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants Having Osteoporosis Related Laboratory Examinations Baseline injection (n = 300, 300)	230 participants	260 participants
Number of Participants Having Osteoporosis Related Laboratory Examinations First post-baseline injection (n = 285, 294)	148 participants	207 participants
Number of Participants Having Osteoporosis Related Laboratory Examinations Second post-baseline injection (n = 280, 286)	162 participants	224 participants
Number of Participants Having Osteoporosis Related Laboratory Examinations Third post-baseline injection (n = 270, 280)	163 participants	226 participants
Number of Participants Having Osteoporosis Related Laboratory Examinations Fourth post-baseline injection (n = 262, 263)	174 participants	223 participants

SECONDARY outcome

Timeframe: 24 months

Population: Full analysis set

Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab ADRs leading to discontinuation of denosumab	2 participants	5 participants
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab All adverse drug reactions	4 participants	12 participants
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab Fatal adverse drug reactions	0 participants	0 participants

SECONDARY outcome

Timeframe: 24 months

Population: Full analysis set

Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.

Outcome measures

Measure	Czech Republic n=300 Participants Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 Participants Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Number of Participants With Serious ADRs to Denosumab All serious adverse drug reactions	0 participants	1 participants
Number of Participants With Serious ADRs to Denosumab SADRs leading to discontinuation of denosumab	0 participants	0 participants
Number of Participants With Serious ADRs to Denosumab Fatal serious ADRs	0 participants	0 participants

Adverse Events

Czech Republic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Slovakia

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Czech Republic n=300 participants at risk Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Slovakia n=300 participants at risk Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Cardiac disorders Myocardial infarction	0.00% 0/300 • 24 months Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions that exceed the indicated frequency threshold. Serious Adverse Events summarizes serious adverse drug reactions which are defined as serious adverse events that are considered related to denosumab.	0.33% 1/300 • 24 months Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions that exceed the indicated frequency threshold. Serious Adverse Events summarizes serious adverse drug reactions which are defined as serious adverse events that are considered related to denosumab.

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER