NCT01652690

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

Completed Results posted Last updated 6 March 2019

What this trial tests

trial testing Denosumab in Osteoporosis, Postmenopausal in 600 participants. Completed in 15 May 2015.

Timeline

26 June 2012

Primary endpoint
15 May 2015

15 May 2015

Quick facts

Lead sponsor	Amgen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	600
Start date	26 June 2012
Primary completion	15 May 2015
Estimated completion	15 May 2015
Sites	29 locations across Slovakia, Czechia

Drugs / interventions tested

• Denosumab (DENOSUMAB) — full drug profile →

Conditions studied

• Osteoporosis, Postmenopausal — all drugs for Osteoporosis, Postmenopausal →

Sponsor

Amgen — full company profile →

Who can join

Eligibility, female only, with Osteoporosis, Postmenopausal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office Primary · 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.

Group	Value	95% CI
Czech Republic	295
Slovakia	296

Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection Primary · Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Baseline injection (n = 300, 300)

Group	Value	95% CI
Czech Republic	300
Slovakia	298

First post-baseline injection (n = 283, 293)

Group	Value	95% CI
Czech Republic	282
Slovakia	291

Second post-baseline injection (n = 276, 283)

Group	Value	95% CI
Czech Republic	275
Slovakia	282

Third post-baseline injection (n = 262, 276)

Group	Value	95% CI
Czech Republic	260
Slovakia	274

Fourth post-baseline injection (n = 246, 243)

Group	Value	95% CI
Czech Republic	245
Slovakia	240

Number of Participants Receiving All Prescriptions and Injections of Denosumab Primary · 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.

First post-baseline injection

Group	Value	95% CI
Czech Republic	283
Slovakia	293

Second post-baseline injection

Group	Value	95% CI
Czech Republic	276
Slovakia	283

Third post-baseline injection

Group	Value	95% CI
Czech Republic	262
Slovakia	276

Fourth post-baseline injection

Group	Value	95% CI
Czech Republic	246
Slovakia	243

Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care Primary · 24 months

Referred to other health care providers (total)

Group	Value	95% CI
Czech Republic	0
Slovakia	2

Referred to rheumatologist

Group	Value	95% CI
Czech Republic	0
Slovakia	2

Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection Primary · 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.

Prescribing Physician

Group	Value	95% CI
Czech Republic	54
Slovakia	84

Other Physician

Group	Value	95% CI
Czech Republic	19
Slovakia	21

Nurse

Group	Value	95% CI
Czech Republic	227
Slovakia	195

Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection Primary · 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.

Prescribing Physician

Group	Value	95% CI
Czech Republic	70
Slovakia	109

Other Physician

Group	Value	95% CI
Czech Republic	8
Slovakia	0

Nurse

Group	Value	95% CI
Czech Republic	205
Slovakia	184

Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection Primary · 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.

Prescribing Physician

Group	Value	95% CI
Czech Republic	75
Slovakia	104

Other Physician

Group	Value	95% CI
Czech Republic	0
Slovakia	0

Nurse

Group	Value	95% CI
Czech Republic	201
Slovakia	179

Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection Primary · 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.

Prescribing Physician

Group	Value	95% CI
Czech Republic	69
Slovakia	113

Other Physician

Group	Value	95% CI
Czech Republic	4
Slovakia	1

Nurse

Group	Value	95% CI
Czech Republic	189
Slovakia	162

Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection Primary · 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.

Prescribing Physician

Group	Value	95% CI
Czech Republic	76
Slovakia	93

Other Physician

Group	Value	95% CI
Czech Republic	0
Slovakia	6

Nurse

Group	Value	95% CI
Czech Republic	170
Slovakia	144

Number of Denosumab Post-baseline Injections Received by Each Participant Primary · 24 months

No post-baseline injections

Group	Value	95% CI
Czech Republic	17
Slovakia	7

One post-baseline injection

Group	Value	95% CI
Czech Republic	7
Slovakia	10

Two post-baseline injections

Group	Value	95% CI
Czech Republic	14
Slovakia	7

Three post-baseline injections

Group	Value	95% CI
Czech Republic	16
Slovakia	33

Four post-baseline injections

Group	Value	95% CI
Czech Republic	246
Slovakia	243

Number of Participants Having Radiologic Bone Assessments Primary · Pre-baseline (before first denosumab injection) and during the study (post-baseline)

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

Pre-baseline

Group	Value	95% CI
Czech Republic	297
Slovakia	299

Post-baseline

Group	Value	95% CI
Czech Republic	253
Slovakia	216

Number of Participants Having Osteoporosis Related Laboratory Examinations Primary · Pre-baseline (before first denosumab injection) and post-baseline

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.

Baseline injection (n = 300, 300)

Group	Value	95% CI
Czech Republic	230
Slovakia	260

First post-baseline injection (n = 285, 294)

Group	Value	95% CI
Czech Republic	148
Slovakia	207

Second post-baseline injection (n = 280, 286)

Group	Value	95% CI
Czech Republic	162
Slovakia	224

Third post-baseline injection (n = 270, 280)

Group	Value	95% CI
Czech Republic	163
Slovakia	226

Fourth post-baseline injection (n = 262, 263)

Group	Value	95% CI
Czech Republic	174
Slovakia	223

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Czech Republic

Serious: 0/300 (0%)

Deaths: —

Slovakia

Serious: 1/300 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Czech Republic	Slovakia
Myocardial infarction	Cardiac disorders	—	—

Most-reported serious reactions: Myocardial infarction.

Data from ClinicalTrials.gov NCT01652690 adverse events section.

Sponsor's own description

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia.
   Růžičková O, Killinger Z, Kasalický P, Hamilton L, et al · · 2018 · cited 4× · PMID 30191465 · DOI 10.1007/s12325-018-0779-9