Safety Assessment Among Women With Postmenopausal Osteoporosis and Men With Osteoporosis in Multiple Observational Databases
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Menopausal Osteoperosis, Male Osteoperosis
Intervention: denosumab (Drug); bisphosphonate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Overall contact: Amgen Call Center, Phone: 866-572-6436
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.
Clinical Details
Official title: Denosumab Global Safety Assessment Among Women With Postmenopausal Osteoporosis and Men With Osteoporosis in Multiple Observational Databases
Study design: Time Perspective: Prospective
Primary outcome: Incidence rates of Adverse Events of Special Interest (AESI)
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
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.
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.
Locations and Contacts
Amgen Call Center, Phone: 866-572-6436
Amgen, Thousand Oaks, California 91320, United States; Recruiting
Additional Information
AmgenTrials clinical trials website
Related publications: Xue F, Ma H, Stehman-Breen C, Haller C, Katz L, Wagman RB, Critchlow CW; Denosumab Global Safety Assessment Team. Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis. Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1107-14. doi: 10.1002/pds.3477. Epub 2013 Jul 15.
Starting date: May 2010
Last updated: August 18, 2015
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