Overview

This trial is active, not recruiting.

Condition post menopausal osteoperosis, male osteoperosis
Treatments denosumab, bisphosphonate
Sponsor Amgen
Collaborator Aarhus University Hospital
Start date May 2010
End date May 2023
Trial size 575462 participants
Trial identifier NCT02520362, 20090522

Summary

This is a prospective open cohort study with annual assessment and reporting of descriptive findings and a final report at the end of the study to address all study objectives. The study period will include 10 years of data accumulated in each data system. The study start date is the denosumab international birth date, 26 May 2010. The data end date will be 10 years after the international birth date, 25 May 2020.The primary 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 Postmenopausal Osteoporosis, and patients who receive Prolia for unapproved indications. Among women with Postmenopausal Osteoporosis, exposure cohorts will be established based on exposure to denosumab or bisphosphonates. Nine adverse events of special interest will be identified using validated algorithms based on inpatient and outpatient diagnosis and procedure codes, and, for some AESI, medication codes or laboratory data. Selected AESI (osteonecoris of the jaw and atypical femoral fracture) will be confirmed by medical chart review.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Postmenopausal Women
Women with post menopausal osteoporosis
denosumab
subcutaneous injection
bisphosphonate
The assessment of bisphosphonates includes branded oral bisphosphonates (eg, alendronate [Fosamax®], risedronate [Actonel®], ibandronate [Boniva®/Bonviva®] oral); generic bisphosphonates, including alendronate, neridodronate, and olpadronate; intravenous bisphosphonates including ibandronate IV, and zoledronate [Reclast®/Aclasta®].
Patients who receive Prolia for unapproved indications
denosumab
subcutaneous injection
Men with osteoporosis treated with denosumab
denosumab
subcutaneous injection

Primary Outcomes

Measure
Incidence rates of Adverse Events of Special Interest (AESI)
time frame: 10 years

Eligibility Criteria

Male or female participants from 55 years up to 99 years old.

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. 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.

Additional Information

Official title Denosumab Global Safety Assessment Among Women With Postmenopausal Osteoporosis and Men With Osteoporosis in Multiple Observational Databases
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Amgen.