Phase 4
N=26
Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01400516 ↗Enrolled (actual)
26
Serious AEs
4.2%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan — 571.4; 369.8; 9.1; -0.4 cubic millimeter (mm^3) — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Teriparatide (Drug); calcium citrate (Drug); Vitamin D (Drug); TNF antagonist (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan |
571.4; 369.8; 9.1; -0.4 | 0.28 |
| SECONDARY Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan |
0.93; 0.91; -0.002; 0.06; 0.73; 0.68 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP) |
2.73; 2.66; -0.50; 0.42 | — |
Summary
Summary:
The investigators propose a randomized controlled open label study of teriparatide in men or women with rheumatoid arthritis and joint erosions. Specifically, the investigators will examine whether teriparatide in combination with a biologic can retard the development of joint erosions. The study will be conducted at Brigham and Women's Hospital Arthritis Center, several Brigham and Women's Hospital Arthritis Center satellite practices, the University of Massachusetts Medical Center, and Massachusetts General Hospital.
Hypothesis:
The investigators hypothesize that the combination of teriparatide with biologic will be much more effective at retarding erosion progression then a biologic alone.
Eligibility Criteria
Inclusion Criteria
All men and women 45 years of age or older with RA and joint erosions by plain x-ray who are taking a biologic for at least three months and who have not taken more than two weeks of a bone active agent in the last 12 months will be eligible and screened for their interest in participating in the proposed randomized trial.
- RA will be defined according to the 2010 American College of Rheumatology/European League Against Rheumatism diagnostic and classification criteria.
- Osteopenic bone mineral density will be defined as a t-score between -1.0 and -2.5 on either a DXA of the posteroanterior (PA) or lateral lumbar spine or the femoral neck or total hip. Potential subjects with prior minimal trauma fractures will be excluded.
2.Subjects must be able to give written informed consent.
Exclusion Criteria
- A switch in DMARD in the last 3 months;
- Current use of chronic oral glucocorticoids > 5 milligrams per day;
- A prior history of intolerance to teriparatide;
- T-score 20 ng/ml), intact PTH, and thyroid stimulating hormone (TSH). If PTH and/or 25-hydroxy vitamin D (25-OH D) levels are abnormal, subjects may be given calcium and/or multivitamin supplements and be re-tested in 2-12 weeks;
- Serum calcium (Ca) > 10.6 mg/dl, and 24-hour urine calcium > 400 mg. If minor abnormalities are detected in any of these parameters, the test may be repeated;
- Patients who have had external beam radiation; and
- Patients currently on digoxin.
- Women that are currently pregnant or breast-feeding or plan on becoming pregnant over the course of participation in the study
Data sourced from ClinicalTrials.gov (NCT01400516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.