Bisphosphonate drug holidays: Factors influencing timing, duration, re-initiation of therapy and attitudes

conceptual illustration of interconnected points

This study concerns related prolonged suppression of bone turnover, and potential adverse events related to long-term use of bisphosphonates have recently led to the practice of provider implementation of “drug holidays” or time off of bisphosphonate therapy. Although there is some evidence supporting safety of undergoing drug holidays, there are few data to guide decisions regarding appropriateness of initiating a drug holiday, or to guide the length of a drug holiday, or what factors can be reliably used to guide stopping a drug holiday (reinitiating therapy). Thus practitioners are making these decisions in the absence of clear evidence based data. This project will help determine what clinical factors providers actually are considering when either initiating a drug holiday or restarting treatment for their osteoporosis patients. This project will seek to identify and understand potential factors influencing the use of drug holidays, including duration of drug holidays, restarting therapy, and patient and provider attitudes towards drug holidays using a multi-pronged approach.

PI: Dr. Erik Imel

Co-PI: Dr. Siu Hui

Merck Team Members: Jessica Weaver

RI Team Members: Ziyue Liu, Andrea Kelley, Rachel Fuhr

VA Team Members: Angela Rollins
Other: ResNet

Start: 2/1/2016 End: 1/31/2017

Aim 1: Using prescription data from Indiana University Health to determine the incidence of the practice of bisphosphonate drug holidays, along with their duration and the clinical factors used to both initiate and end drug holidays.

Aim 2: Using a targeted survey of physicians identified as prescribing bisphosphonates, we will conduct a survey to determine the factors being used in their decisions regarding bisphosphonate drug holidays.

Aim 3: The team will survey patients to garner osteoporosis patient attitudes towards bisphosphonate drug holidays (whether positive or negative, and associated reasons) and re-initiation of treatment.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Richard L. Roudebush VA Medical Center

The protocol for the database study (Aim 1) has been reviewed and approved by the Investigational Review Board (IRB) and by the Merck Document Review Committee (DRC).

The study team is currently developing the questions to be included in the physician and patient surveys as part of the protocol for Aims 2 & 3.