drugset / Trial / NCT02944799

Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

NCT02944799

Phase 2 Completed 69 enrolled University of Aarhus
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-12
Primary completion
2021-12-20
Completion
2021-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alendronic Acid Small molecule 70 mg Oral
Comparator Calcium carbonate Other / unclassified 800 mg
Comparator Vitamin D Other / unclassified 38 ug