Denosumab Safety Assessment in Multiple Observational Databases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

517991 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2023-07-21

Brief Summary

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This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare, Optum Research Database (formerly United HealthCare), Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. The study period will include up to 10 years in each data system depending on data availability. Descriptive statistics will be used to characterize cohorts with respect to patient characteristics and utilization patterns. Person-year adjusted AESI incidence rates will be calculated among postmenopausal women, postmenopausal women with osteoporosis, and exposure cohorts with a final comparative safety analysis. Subsequent sub-studies using US data systems were added to describe men with osteoporosis treated with Prolia and men and women who receive Prolia with glucocorticoid exposure.

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Detailed Description

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This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare,Optum Research Database (formerly United HealthCare), Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. The study period will include up to 10 years in each data system depending on data availability. Descriptive statistics will be used to characterize exposure cohorts with respect to patient characteristics, clinical features, and AESI risk factors. Person-year adjusted AESI incidence rates will be calculated among postmenopausal women, postmenopausal women with osteoporosis, and exposure cohorts. Exploratory analyses comparing incidence rates of AESI in women with PMO adjusting for potential confounders will also be conducted. Descriptive statistics will be used to characterize denosumab utilisation patterns in patients who receive denosumab for PMO and in subjects who receive Prolia therapy for unapproved indications. Subsequent substudies using US data systems were added to describe men with osteoporosis treated with Prolia and men and women who receive Prolia with glucocorticoid exposure.

Conditions

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Osteoporosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Postmenopausal Women

No interventions assigned to this group

Women with post menopausal osteoporosis

denosumab

Intervention Type DRUG

subcutaneous injection

bisphosphonate

Intervention Type DRUG

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 \[Reclast®/Aclasta®\].

Prolia for unapproved indications

Patients who receive Prolia for unapproved indications

denosumab

Intervention Type DRUG

subcutaneous injection

Men with osteoporosis

Men with osteoporosis treated with denosumab

denosumab

Intervention Type DRUG

subcutaneous injection

Men and women who receive Prolia with Glucocorticoid exposure

Drug: denosumab subcutaneous injection

No interventions assigned to this group

Interventions

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denosumab

subcutaneous injection

Intervention Type DRUG

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 \[Reclast®/Aclasta®\].

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

• Women with postmenopausal osteoporosis: Women with Paget'sdisease 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.

* 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.

• Men and 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 the index date will be excluded. Men and women with Paget's disease during the 12-month period prior to the index date will also be excluded. The exclusion of subjects with cancer or Paget's disease will ensure that subjects included in the substudy are receiving denosumab for the treatment of osteoporosis, and not for other indications.

Minimum Eligible Age

30 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No