Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France

NCT02347865 | Completed

• 1 other identifier: 20130240
• Study Type: observational
• Target: 777
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

Conditions

Post Menopausal Osteoporosis

Keywords

osteoporosis post menopausal women

Outcome Measures

Primary Outcomes (1)

• patient occurence of persistence (persistence is defined in the outcome description) at 12 months

  To evaluate the persistence with Prolia at 12 months in post menopausal women with osteoporosis (PMO) in France. To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 12 months if the patient receives at least 2 injections and the second injection at 6 months is no later than 6 months + 8 weeks (or 239 days) from the baseline injection

  12 months

Secondary Outcomes (4)

• patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months

  24 months

• describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection

  30 months from first injection

• patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice

  30 months or early termination

• Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study

  30 months or early termination

Study Arms (2)

wave 1

postmenopausal women with osteoporosis treated with Prolia

Drug: AMG 162 - Prolia

wave 2

postmenopausal women with osteoporosis treated with Prolia

Drug: AMG 162 - Prolia

Interventions

AMG 162 - Prolia DRUG

500 patients

Also known as: denosumab

wave 1

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

post menopausal women with osteoporosis, treated with Prolia

You may qualify if:

• post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks
• received their first prescription of Prolia in the last 4 weeks
• patient has provided informed consent before enrolling in the study

You may not qualify if:

• patients participating in ongoing or previous Denosumab clinical trials

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Amgen

Paris, 92200, France

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 27, 2015
• Study Start: June 16, 2015
• Primary Completion: October 26, 2017
• Study Completion: September 27, 2018
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

FR (1)