drugset / Trial / NCT02944799
Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | Oral |
| Comparator | Calcium carbonate | Other / unclassified | 800 mg | — |
| Comparator | Vitamin D | Other / unclassified | 38 ug | — |