Effects of Denosumab on the Pharmacokinetics of Etanercept
Status: | Terminated |
---|---|
Conditions: | Arthritis, Osteoporosis, Postmenopausal Syndrome, Rheumatoid Arthritis, Women's Studies, Gastrointestinal |
Therapuetic Areas: | Endocrinology, Gastroenterology, Rheumatology, Reproductive |
Healthy: | No |
Age Range: | 45 - 80 |
Updated: | 4/21/2016 |
Start Date: | March 2011 |
End Date: | January 2016 |
The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis
This is a multi-center, open-label, single sequence, denosumab single-dose study in
postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis (RA) being
treated with etanercept.
postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis (RA) being
treated with etanercept.
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 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
We found this trial at
2
sites
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