Treatment of osteoporosis in patients with rheumatoid arthritis.

Phase 1

• Conditions: Rheumatoid arthritis and osteoporosis; MedDRA version: 20.0Level: LLTClassification code 10031289Term: Osteoporosis, unspecifiedSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10039076Term: Rheumatoid arthritis and other inflammatory polyarthropathiesSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-003638-28-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-28
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

-Patients (> 18 years) with rheumatoid arthritis according to the ACR/EULAR (2010) classification criteria (10)
-patients must have been treated with oral bisphosphonatesalendronate for 5 years or longer, the last three years with alendronate
-current T-score on DXA better than or equal to -2,5 (femoral) and -3,0 (vertebral)
-receiving treatment on an outpatient basis
-negative pregnancy test (serum HCG) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. Plasma T1/2 of ALN is less than 2 hours. The forms of contraception include: intrauterine device (IUD) and hormonal anticontraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bitalteral tubectomy, hysterectomy and bilateral ooferectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment. Postmenopause will be confirmed by measurement of s-FSH prior to enrollment.
-ability and willingness to give written informed consent and to meet the requirements of the trial protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- history of hip fracture due to osteoporosis
-- history of vertebral fragility fractures within the last three years OR fragility fractures in more than two vertebrae
-- history of non-vertebral fragility fractures (fingers and toes not included) within the last three years
-osteonecrosis of the jaw.
-history of or ongoing systemic GC treatment within the last 6 months (intraarticular injections are approved)
-known allergy toward any components of the study medicine
-prior or ongoing treatment with with BPs other than ALN or other antiosteoporosis drugs such as hormone replacement therapy (HRT) or teriparatide (low-dose HRT up to 1mg/day is accepted)
-evidence of active malignant disease
-metabolic bone disease other than osteoporosis
-hypo- or hyperthyroidism
-hypocalcaemia
-impaired renal function (eGFR <35ml/min)
-known disease of the esophagus that might impair the ability to swallow the tablets such as achalasia, dysphagia or strictures
-history of upper gastrointestinal disease within 1 year prior to enrollment such as peptic ulcer, upper GI bleeding, gastritis, duodenitis or surgical procedures to the upper GI-tract
-allergy towards any of the substances in the study medicine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified