Is Intravenous Bisphosphonate Use Associated with a Higher Risk of a Flare in Inflammatory Bowel Disease Patients? (Bisphosphonates and IBD Flare Risk)

Study identification

• EU PAS number:
  EUPAS32010
• Study ID:
  36589
• Official title and acronym:
  Is Intravenous Bisphosphonate Use Associated with a Higher Risk of a Flare in Inflammatory Bowel Disease Patients? (Bisphosphonates and IBD Flare Risk)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Specific Aims: 1. To describe patients with inflammatory bowel disease that are being treated with intravenous and oral bisphosphonate therapyHypothesis: We hypothesize that the majority of IBD patients treated with bisphosphonates are older and receive oral bisphosphonates2. To determine if intravenous bisphosphonate therapy is associated with an increased risk of flare of IBD activity, as measured by a new prescription for a corticosteroid or an IBD-related emergency room visit or hospitalization, compared with oral bisphosphonate therapy Hypothesis: We hypothesize that intravenous bisphosphate therapy will be significantly associated with a flare of disease activity
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Study timelines

Date when funding contract was signed

Planned: 02/11/2019

Actual: 02/11/2019

Study start date

Planned: 02/11/2019

Actual: 02/11/2019

Data analysis start date

Planned: 02/11/2019

Actual: 02/11/2019

Date of final study report

Planned: 31/12/2020

Sources of funding

Other

More details on funding

National Institutes of Health, Royster Society of Fellows

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable