Jul 03, 2023
Changes in Bone Mineral Density and Incidence of Fractures during Two Years of Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis: Protocol for a Systematic Review and Individual Participant Data Meta-Analysis
- 1Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Germany
Protocol Citation: Andriko Palmowski 2023. Changes in Bone Mineral Density and Incidence of Fractures during Two Years of Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis: Protocol for a Systematic Review and Individual Participant Data Meta-Analysis. protocols.io https://dx.doi.org/10.17504/protocols.io.6qpvr3ombvmk/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Other
This is a systematic reivew protocol.
Created: July 03, 2023
Last Modified: July 03, 2023
Protocol Integer ID: 84382
Funders Acknowledgement:
Elsbeth Bonhoff Stiftung
Grant ID: 244
The Oak Foundation
Grant ID: OCAY-18-774-OFIL
Abstract
Background
Glucocorticoids (GCs) are regularly used drugs in the treatment of rheumatoid arthritis (RA), and lower bone mineral density and fractures are common adverse effects of the treatment with higher GC dosages. However, the effects of low dose (i.e., ≤7.5mg/day) and very low dose (i.e., ≤5mg/day) treatment over longer periods of time (i.e., ≥ 24 months), as often seen in RA, have not been fully elucidated yet.
Objective
To conduct a systematic review and meta-analysis of individual patient data from long-term randomized controlled trials (RCTs) in RA, which compared low dose GCs to a control treatment, in order to investigate the effects on bone mineral density and incidence of fractures (clinical/symptomatic).
Methods
We will search the literature to identify published trials which collected data on bone mineral density and/or the incidence of fractures. This will be followed by the acquisition of individual participant data. Included RCTs will be combined to compare bone mineral density and fractures in GC and control groups. To underpin our findings, we will perform additional analyses to identify potential effect modifiers and a sensitivity analysis related to missing data.
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Protocol.pdf