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Amgen Bone Health Mentoring Program

Monday, October 15, at 11:30am – 2:30pm ◼ Ruth Chris, Minneapolis, MN

FR0360 A Phase IIb Study of MK-5442 Calcium Sensing
Receptor (CaSR)Antagonist in Bisphosphonate-treated
Patients.
Cosman F, Gilchrist N, McClung M, et al
Session: Welcome Reception and Plenary Poster Session
◼ Friday, October 12, 05:45 PM - 07:00 PM ◼ Discovery
Hall-Hall B/Minneapolis Convention Center

Background/ Abstract Information Additional Notes from
Objective Poster/Presentation*
▪ Previous studies indicate that MK-5442
Methods increases BMD in treatment naïve Strengths,
osteoporotic PMW. Weaknesses, Key
Points
▪ The present study assessed the effects on
BMD and bone turnover associated with
switching from long-term bisphosphonate
therapy to MK-5442 in patients with low
bone mass.

▪ This dose-finding study enrolled 526 PMW
with prior ALN for at least 1 year and an
oral bisphosphonate for >3 of the 4 years
before the trial.

▪ PMW with spine or hip BMD T-scores #-
2.5 (or ≤-1.5 with >1 prior fragility fracture)
and >-4.0 were randomized to continue
ALN or switch to either PBO or MK-5442
(5, 7.5, 10 or 15 mg daily).

▪ Primary endpoint: Change from baseline in
LS BMD with MK-5442 as compared to
continued ALN at 12 months.

▪ Additional endpoints: Change from
baseline in total hip aBMD, u-NTx, s-
P1NP, serum calcium, s-PTH, and safety.

* Assignment notes will be collected at the Amgen Mentoring Program Debrief Meeting. Hardcopy or Electronic versions are acceptable