Protocol Amendment – Summary Table of Changes with Rationale Table

[A summary table of changes as described in the sample below is a helpful way to outline changes between versions of the study protocol. Include all proposed changes, including typographical changes. The notes in red are instructional and should be deleted before submitting to the Sunnybrook Research Ethics Board (REB).]

REB PIN/Full Study Title

Summary Table of Changes from Protocol Version 1.0 dated Month day, year. to Protocol Version 1.1 dated Month day, year. Sample Protocol Version 1.0 Protocol Version 1.1 Rationale dated Month day, year dated Month day, year 1 Hypothesis and Objectives, page 4 1 Hypothesis and Objectives, page 4 We plan to stratify subjects who are enrolled This randomized, double-blind, placebo- This randomized, double-blind, placebo- based on this revised BMD inclusion criteria controlled trial will determine the efficacy of controlled trial will determine the efficacy of (protocol version 1.1 dated March xx, 200x) Risedronate 35 mg weekly versus placebo Risedronate 35 mg weekly versus placebo with versus the inclusion criteria of protocol version with standard care for eighteen months, on standard care for eighteen months, on changes 1.0 dated July x, 200x. We have elevated our changes in BMD of the distal femur in 44 in BMD of the distal femur in 46 subjects with SCIsample size by two subjects (n=46) to allow for subjects with SCI and osteopenia of the hip and osteopenia of the hip region. an additional degree of freedom in our statistical region. analysis. 16 Randomization, page 10 16 Randomization, page 10 Correction of typing error. This will enable the subject’s trial physician to This will enable the subject’s treating physician to obtain access to the subjects’ intervention obtain access to the subjects’ intervention allocation from the pharmacy binder 24 hours allocation from the pharmacy binder 24 hours per per day in the event of an emergency. day in the event of an emergency.

REB PIN/Full Study Title

Summary Table of Changes from Protocol Version 1.0 dated Month day, year. to Protocol Version 1.1 dated Month day, year.

Protocol Version No. Protocol Version No. Rationale Date Date