Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, placebo-controlled trial including 160 consecutive patients who have been diagnosed with both rheumatoid arthritis (RA) and low bone mass and have been treated with alendronate (ALN) for five years or more. Patients will be randomized to discontinuation or continuation of alendronate. Outcomes are measured using dual energy absorptiometry (DXA), High Resolution peripheral Quantitative Computer Tomography (HR-pQCT) and biochemical markers of bone metabolism and inflammation after 6 months, 1 and 2 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Alendronate; Calcium; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Patients (> 18 years) with rheumatoid arthritis according to the ACR(1987 or 2010)/EULAR (2010) classification criteria (12)

• treated with alendronate for five years or more

• 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 / bilateral tubectomy, hysterectomy and bilateral oophorectomy) 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.

Exclusion Criteria:

• history of hip fracture due to osteoporosis

• history of vertebral fracture of more than one vertebrae or other fragility fractures within the last three years (fingers and toes not included)

• 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 other antiosteoporosis drugs such as hormone replacement therapy or teriparatide

• 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