Denosumab Safety Assessment in Multiple Observational Databases

• Status: Active, not recruiting
• Trial end date: 2024-08-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources. The study period will include up to 10 years in each data system. The secondary data sources will be the following: *US Medicare, including Parts A, B, and D* United HealthCare* Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. Data will be collected for postmenopausal women overall, women with PMO, and patients who receive Prolia for unapproved indications.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborators: Aarhus University Hospital; OPTUM Insight; Optum, Inc.; University of Alabama at Birmingham
• Treatments: Denosumab; Diphosphonates

Criteria

Inclusion Criteria for women with postmenopausal osteoporosis:

• Postmenopausal women: Postmenopausal status will be determined based on age and defined as women ≥ 55 years old. For the Medicare database, only women ≥ 65 years old will be included in the analysis, given that generally all individuals in the US ≥ 65 years old are eligible for Medicare coverage and data on postmenopausal women less than 65 years old will be available for only a small number of women meeting other specialized eligibility criteria.

• Women with Post Menopausal Osteoporosis: The presence of Post Menopausal Osteoporosis will be determined utilizing an algorithm based upon definition of postmenopausal women (≥ 65 years old in Medicare or ≥ 55 years old in other data systems), diagnostic codes indicating osteoporosis, diagnostic codes indicating osteoporotic fracture, and/or relevant postmenopausal osteoporosis treatment codes.

• The inclusion of men and women who have Glucocorticoid Induced Osteoporosis (GIOP) has also been added to the study population. Men and women who receive Prolia with glucocorticoid exposure are included in the ongoing study 20090522 to assess safety in the post-marketing environment

Exclusion Criteria for women with postmenopausal osteoporosis:

• Women with postmenopausal osteoporosis: Women with Paget's disease during the 12-month period prior to meeting criteria for inclusion in postmenopausal osteoporosis population will be excluded. Additionally, in US Medicare and United Healthcare, women with a diagnosis of malignancy (excluding non-melanoma skin cancer) or treatment with chemotherapy, hormonal therapy or radiation therapy for cancer up to 12-months before index date will be excluded. In the Scandinavian national registries, women with a diagnosis of cancer according to the patient registry and/or cancer registry up to 12-months prior to meeting criteria for inclusion in postmenopausal osteoporosis population will be excluded.

Inclusion criteria for men with osteoporosis:

• Men ≥ 65 years old in the Medicare database or ≥ 30 years old in United Healthcare who receive at least one denosumab 60 mg injection will be included. All men need to be continuously enrolled for at least 12 months prior to start of follow-up. A diagnosis code of osteoporosis or osteoporotic fracture would not be required because it is known that male osteoporosis is under-diagnosed. The exclusion of patients with cancer or Paget disease (as described in the Exclusion Criteria Section) will ensure that patients treated with Prolia is for osteoporosis but not for other indications. The index date is defined as the date when a patient first satisfies all inclusion criteria.

Exclusion Criteria for men with osteporosis:

• Men with a diagnosis of malignancy (excluding non-melanoma skin cancer) or treatment with chemotherapy, hormonal therapy or radiation therapy for cancer up to 12 months before the index date will be excluded.

• Men with Paget's disease during the 12-month period prior to the index date will also be excluded.