DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Teriparatide (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Daniel H Solomon, MD, MPH, Principal Investigator, Affiliation: Brigham and Women's Hospital
Ellen M. Gravallese, MD, Principal Investigator, Affiliation: University of Massachusetts, Worcester
Jonathan Kay, MD, Principal Investigator, Affiliation: University of Massachusetts, Worcester
Marcy B. Bolster, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

Official title: Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Joint Erosion by 3D CT scan

Secondary outcome: Lumbar by DXA

Detailed description: I. Introduction: While generalized osteoporosis causes tremendous disability in patients with RA and occurs relatively frequently in such patients, there has been little research on treatments for osteoporosis in patients with RA. Not only are there important questions about the effects of teriparatide on BMD in patients with RA, but little is known about how it might affect localized bone erosions or RA disease activity. Recent data in a mouse model of RA suggest that intermittent PTH in the setting of potent immunosuppressives may indeed heal bone erosions. This study showed an additive effect of PTH in addition to a biologic on erosion healing. To the best of our knowledge, this has yet to be demonstrated in humans. That is the primary aim of the proposed study. II. Objectives and Hypotheses: To assess the effects of teriparatide among a group of patients with RA and erosions, all using biologics, with respect to: 1. Joint erosion volume by 3D CT scan; 2. Lumbar BMD by DXA; 3. Hip BMD by DXA; and 4. RA disease activity measured by the Disease Activity Score (DAS) and acute phase reactants. The hypotheses to be tested include: 1. Joint erosion scores, measured by 3D CT scan, will be significantly improved at study completion in patients taking teriparatide. 2. Teriparatide will significantly increase BMD at all sites as measured by DXA. 3. RA disease activity measures will be stable during the study year.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

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. 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 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 TSH. If PTH and/or 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 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

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Massachusetts Medical School, Worcester, Massachusetts 01605, United States

Additional Information

Brigham and Women's Clinical Trials

Related publications:

Rasch EK, Hirsch R, Paulose-Ram R, Hochberg MC. Prevalence of rheumatoid arthritis in persons 60 years of age and older in the United States: effect of different methods of case classification. Arthritis Rheum. 2003 Apr;48(4):917-26.

Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30.

Hooyman JR, Melton LJ 3rd, Nelson AM, O'Fallon WM, Riggs BL. Fractures after rheumatoid arthritis. A population-based study. Arthritis Rheum. 1984 Dec;27(12):1353-61.

Michel BA, Bloch DA, Wolfe F, Fries JF. Fractures in rheumatoid arthritis: an evaluation of associated risk factors. J Rheumatol. 1993 Oct;20(10):1666-9.

Spector TD, Hall GM, McCloskey EV, Kanis JA. Risk of vertebral fracture in women with rheumatoid arthritis. BMJ. 1993 Feb 27;306(6877):558.

Hall GM, Spector TD, Griffin AJ, Jawad AS, Hall ML, Doyle DV. The effect of rheumatoid arthritis and steroid therapy on bone density in postmenopausal women. Arthritis Rheum. 1993 Nov;36(11):1510-6.

Cooper C, Coupland C, Mitchell M. Rheumatoid arthritis, corticosteroid therapy and hip fracture. Ann Rheum Dis. 1995 Jan;54(1):49-52.

Saag KG, Emkey R, Schnitzer TJ, Brown JP, Hawkins F, Goemaere S, Thamsborg G, Liberman UA, Delmas PD, Malice MP, Czachur M, Daifotis AG. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998 Jul 30;339(5):292-9.

Cohen S, Levy RM, Keller M, Boling E, Emkey RD, Greenwald M, Zizic TM, Wallach S, Sewell KL, Lukert BP, Axelrod DW, Chines AA. Risedronate therapy prevents corticosteroid-induced bone loss: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 1999 Nov;42(11):2309-18.

Adachi JD, Bensen WG, Brown J, Hanley D, Hodsman A, Josse R, Kendler DL, Lentle B, Olszynski W, Ste-Marie LG, Tenenhouse A, Chines AA. Intermittent etidronate therapy to prevent corticosteroid-induced osteoporosis. N Engl J Med. 1997 Aug 7;337(6):382-7.

Lane NE, Sanchez S, Modin GW, Genant HK, Pierini E, Arnaud CD. Parathyroid hormone treatment can reverse corticosteroid-induced osteoporosis. Results of a randomized controlled clinical trial. J Clin Invest. 1998 Oct 15;102(8):1627-33.

Eggelmeijer F, Papapoulos SE, van Paassen HC, Dijkmans BA, Valkema R, Westedt ML, Landman JO, Pauwels EK, Breedveld FC. Increased bone mass with pamidronate treatment in rheumatoid arthritis. Results of a three-year randomized, double-blind trial. Arthritis Rheum. 1996 Mar;39(3):396-402.

Starting date: August 2011
Last updated: July 9, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017