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Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial (TERA)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01400516
First received: July 21, 2011
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Teriparatide
Drug: calcium citrate
Drug: Vitamin D
Drug: TNF antagonist

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Arm The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
Teriparatide The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.

Participant Flow for 2 periods

Period 1:   Primary Trial
    Control Arm   Teriparatide
STARTED   12   14 
COMPLETED   12   12 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                2 

Period 2:   Extension Trial
    Control Arm   Teriparatide
STARTED   6 [1]   7 [2] 
COMPLETED   6   7 
NOT COMPLETED   0   0 
[1] Only 6 participants in the Control arm entered the Extension Trial.
[2] Only 7 participants in the Teriparatide arm entered the Extension Trial.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.

Reporting Groups
  Description
Control Arm The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
Teriparatide The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
Total Total of all reporting groups

Baseline Measures
   Control Arm   Teriparatide   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 61 
 (56 to 65) 
 63 
 (56 to 69) 
 62 
 (56 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  75.0%      9  75.0%      18  75.0% 
Male      3  25.0%      3  25.0%      6  25.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan   [ Time Frame: Baseline and Month 12 ]

2.  Secondary:   Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan   [ Time Frame: Baseline and Month 12 ]

3.  Secondary:   Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)   [ Time Frame: Baseline and Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Daniel H Solomon, MD, MPH
Organization: Brigham and Women's Hospital
e-mail: dsolomon@partners.org


Publications:


Responsible Party: Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01400516     History of Changes
Other Study ID Numbers: 2010P002691
Study First Received: July 21, 2011
Results First Received: February 28, 2017
Last Updated: February 28, 2017