Effects of Denosumab on the Pharmacokinetics of Etanercept

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01294397
First received: January 13, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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
Postmenopausal
Osteopenia
Rheumatoid Arthritis
Osteoporosis
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.
Etanercept
All 44 subjects will receive etanercept.
Drug: Denosumab
All 44 subjects will receive a single 60-mg dose of denosumab.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
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
Amgen
Investigators
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:
Amgen
Phase 1
Postmenopausal
Osteopenia
Rheumatoid
Bone Mineral Density
Arthritis
Pharmacokinetics
Osteoporosis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Bone Diseases, Metabolic
Osteoporosis
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
Analgesics
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 September 14, 2014