Drug intelligence / Profile preview

placebo + alendronate

Development stage
Unknown
Lead developer
Merck
Modality
Small Molecules
Administration
Oral, Subcutaneous
01

Overview

This combination regimen refers to the active comparator arm used in a Phase 2 clinical trial (NCT06144125) led by Nitin Agarwal at the University of Pittsburgh. The regimen consists of a weekly oral dose of **alendronate** (70 mg) and a monthly subcutaneous injection of a **placebo** designed to mimic the appearance and administration of romosozumab. Alendronate is a nitrogen-containing bisphosphonate that acts as an antiresorptive agent by inhibiting the enzyme farnesyl pyrophosphate synthase in osteoclasts, thereby reducing bone turnover and increasing bone mineral density. The placebo component is pharmacologically inactive and is utilized to maintain the double-blind, double-dummy study design. The trial specifically evaluates whether romosozumab is superior to standard-of-care alendronate in improving bone strength and surgical outcomes for postmenopausal women with osteoporosis undergoing lumbar spine surgery.

Brand names
Fosamax
Other names
Placebo Romosozumab + AlendronateAlendronate + Placebo
02

Targets

FDPS (Farnesyl pyrophosphate synthase)

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