Primary outcomeMedian· Baseline and Month 12
Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan
| Group | Value (cubic millimeter (mm^3)) |
|---|---|
| Control Arm | 571.4 |
| Teriparatide | 369.8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataTeriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial
Short name TERA
NCTNCT01400516 (opens ClinicalTrials.gov in a new tab)Other id2010P002691
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 26 participants (actual)
- Sponsor
- Brigham and Women's Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Aug 2011
- Primary completion
- 30 Jul 2015
- Completion
- 28 Jul 2016
- First posted
- 22 Jul 2011 (estimated)
- Last update posted
- 11 Apr 2017
- Conditions
- Rheumatoid Arthritis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2011201220132014201520162017
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- TeriparatideDrug
- calcium citrateDrug
- Vitamin DDrug
- TNF antagonistDrug
Arms2
Experimental
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.
Other
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan
Time frame · Baseline and Month 12
Registry description
Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.
Secondary outcomes(2)
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
Registry description
BMD was measured at the lumbosacral spine antero-posterior and at the femoral neck using a densitometer. A positive change from Baseline (increased bone density) indicates improvement.
Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)
Time frame · Baseline and Month 12
Registry description
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· Baseline and Month 12
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan
| Group | Value (grams/centimeters squared (g/cm^2)) | Spread |
|---|---|---|
| Control Arm | 0.93 | 0.11 |
| Teriparatide | 0.91 | 0.09 |
Secondary outcomeMean· Baseline and Month 12
Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Control Arm | 2.73 | 1.19 |
| Teriparatide | 2.66 | 1.43 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Control ArmThe 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. | – | 0 / 12 | 2 / 12 |
| TeriparatideThe 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. | – | 1 / 12 | 8 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2017
6 results
Effects of Teriparatide on Joint Erosions in Rheumatoid Arthritis: A Randomized Controlled Trial.
Solomon et al. 2017Arthritis & rheumatology (Hoboken, N.J.)cited by 30
PMID 28544807DOI 10.1002/art.40156PUB-28544807
Rights unknown6 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 45 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
1. RA will be defined according to the 2010 American College of Rheumatology/European League Against Rheumatism diagnostic and classification criteria.
2. 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:
1. A switch in DMARD in the last 3 months;
2. Current use of chronic oral glucocorticoids \> 5 milligrams per day;
3. A prior history of intolerance to teriparatide;
4. T-score \< -2.5 or a prior minimal trauma fracture;
5. Use of a bone active agent for over 2 weeks in the last 12 months (these agents include oral and intravenous bisphosphonates, hormone replacement therapy, calcitonin, raloxifene, teriparatide, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day or anticonvulsants);
6. History of significant cardiac, hepatic, current alcohol abuse, or major psychiatric disorders;
7. Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years;
8. No current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease. All participants will be required to have normal serum levels of 25-OH vitamin D (\> 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;
9. 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;
10. Patients who have had external beam radiation; and
11. Patients currently on digoxin.
12. Women that are currently pregnant or breast-feeding or plan on becoming pregnant over the course of participation in the study
PepBank is a research reference. Talk to a doctor before you use any peptide.