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Safety Assessment Among Women With Postmenopausal Osteoporosis and Men With Osteoporosis in Multiple Observational Databases

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ClinicalTrials.gov Identifier: NCT02520362
Recruitment Status : Active, not recruiting
First Posted : August 11, 2015
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
Aarhus University Hospital
OPTUM Insight
University of Alabama at Birmingham
Information provided by (Responsible Party):
Amgen

Brief 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.

Condition or disease Intervention/treatment
Post Menopausal Osteoperosis, Male Osteoperosis Drug: denosumab Drug: bisphosphonate

Study Type : Observational
Estimated Enrollment : 575462 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Denosumab Global Safety Assessment Among Women With Postmenopausal Osteoporosis and Men With Osteoporosis in Multiple Observational Databases
Actual Study Start Date : May 31, 2010
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : May 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab

Group/Cohort Intervention/treatment
Postmenopausal Women
Postmenopausal Women
Women with post menopausal osteoporosis
Women with post menopausal osteoporosis
Drug: denosumab
subcutaneous injection

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®].

Prolia for unapproved indications
Patients who receive Prolia for unapproved indications
Drug: denosumab
subcutaneous injection

Men with osteoporosis
Men with osteoporosis treated with denosumab
Drug: denosumab
subcutaneous injection




Primary Outcome Measures :
  1. Incidence rates of Adverse Events of Special Interest (AESI) [ Time Frame: 10 years ]
    Incidence rates of AESI (per 100,000 Person-years) will be assessed by exposure cohort (denosumab or bisphosphonates (overall, oral or IV)).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Three study populations will be identified based on the following inclusion and exclusion criteria. Patients in Medicare and United HealthCare will need to have appropriate plan coverage to be included in any of the following populations. Appropriate plan coverage for the United HealthCare database refers to both pharmacy and medical plan coverage. Appropriate plan coverage for the US Medicare database refers to enrollment in traditional fee-for-service Medicare (Medicare Parts A and B coverage and not in a Medicare Advantage plan), plus Part D. The requirement of 12-months of continuous enrollment is not relevant for Scandinavian national registries because all citizens are enrolled in the universal health coverage from birth to death unless they move out of the country.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520362


Sponsors and Collaborators
Amgen
Aarhus University Hospital
OPTUM Insight
University of Alabama at Birmingham
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02520362     History of Changes
Other Study ID Numbers: 20090522
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://www.amgen.com/datasharing

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs