Effects of Denosumab on the Pharmacokinetics of Etanercept

This study is currently recruiting participants.
Verified March 2014 by Amgen
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 13, 2011
Last updated: March 3, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Etanercept
Drug: Denosumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Area under the serum concentration-time curve (AUC) from 0 to 168 hours for etanercept. [ Time Frame: A period of 21 days following denosumab administration. ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) for etanercept. [ Time Frame: A period of 21 days following denosumab administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum serum concentration (tmax) for etanercept. [ Time Frame: A period of 21 days following denosumab administration. ] [ Designated as safety issue: No ]
  • Serum denosumab concentration. [ Time Frame: At 14 and 21 days following denosumab administration. ] [ Designated as safety issue: No ]
  • Serum C-telopeptide (sCTx) concentrations. [ Time Frame: A period of 168 days following denosumab administration. ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Denosumab
All 44 subjects will receive denosumab.
Drug: Etanercept
All 44 subjects will continue to receive a 50-mg dose of etanercept once weekly.
All 44 subjects will receive etanercept.
Drug: Denosumab
All 44 subjects will receive a single 60-mg dose of denosumab.


Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294397

Contact: Amgen Call Center 866-572-6436

United States, Pennsylvania
Research Site Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01294397     History of Changes
Other Study ID Numbers: 20101324
Study First Received: January 13, 2011
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Phase 1
Bone Mineral Density

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Bone Diseases, Metabolic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014