Effects of Denosumab on the Pharmacokinetics of Etanercept

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-01-31

Brief Summary

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The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).

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Detailed Description

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Conditions

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Postmenopausal Osteopenia Rheumatoid Arthritis Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept + Denosumab

Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Administered by subcutaneous injection once a week

Denosumab

Intervention Type DRUG

Administered by subcutaneous injection

Interventions

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Etanercept

Administered by subcutaneous injection once a week

Intervention Type DRUG

Denosumab

Administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Enbrel® Prolia®

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting for at least 12 months)
* Low bone mineral density (BMD) as determined by screening BMD T-scores of the lumbar spine (L1 to L4), or total evaluable vertebrae (if fewer than L1 to L4), or total hip ≤ -1.0
* Receiving a 50 mg dose of etanercept once weekly ≥ 6 months prior to screening and expected to continue etanercept treatment at this dose and frequency through end of study (EOS)
* If currently taking methotrexate (MTX), receiving a stable dose (7.5 to 20 mg/week) of MTX ≥ 8 weeks prior to screening
* Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 IU vitamin D daily upon enrollment

Exclusion Criteria

* Type 1 diabetes; OR poorly controlled Type 2 diabetes (hemoglobin A1c (HbA1c) \> 8.0% at screening; HbA1c ≤ 8.0% within 6 months of screening is acceptable if supporting laboratory documentation is available)
* History of heart failure, coronary artery bypass graft, or cardiac arrhythmia; OR history of acute coronary syndrome
* Comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities
* History of joint replacement in hand and/or wrist; OR history of fused joint in hand and/or wrist
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; OR active dental or jaw condition that requires oral surgery, or non-healed dental/oral surgery; OR planned invasive dental procedure(s) during the course of the study
* Previous exposure to denosumab

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No