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Terminated/Withdrawn
Sponsor ID
20101324

Effects of Denosumab on the Pharmacokinetics of Etanercept

Sponsor ID
20101324
Clinicaltrials.gov ID
NCT01294397
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 1
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
19
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area under the serum concentration-time curve (AUC) from 0 to 168 hours for etanercept.

Timeframe: A period of 21 days following denosumab administration.

Maximum observed serum concentration (Cmax) for etanercept.

Timeframe: A period of 21 days following denosumab administration.

Secondary Outcome Measures

Time to maximum serum concentration (tmax) for etanercept.

Timeframe: A period of 21 days following denosumab administration.

Serum denosumab concentration.

Timeframe: At 14 and 21 days following denosumab administration.

Serum C-telopeptide (sCTx) concentrations.

Timeframe: A period of 168 days following denosumab administration.

Locations

Location
Status
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Location
Research Site
Dallas, TX, United States, 75231
Status
Recruiting
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Study Info
Age
45 - 80 Years
Condition
  • Osteoporosis
    • Show more
  • Bone Pain
  • Rheumatoid Arthritis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Mar 2011 - Jan 2016
    Inclusion and Exclusion Criteria
    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