Strontium Ranelate (DB09267): A Comprehensive Pharmacological and Clinical Monograph

Section 1: Introduction and Drug Profile

1.1. Overview: A Novel Agent with a Complex Legacy

Strontium ranelate represents a unique chapter in the history of osteoporosis treatment. Developed by the French pharmaceutical company Servier Laboratories and first introduced to the European market in 2004 under brand names such as Protelos® and Osseor®, it was positioned as a groundbreaking therapeutic agent for severe osteoporosis.[1] Its primary indication was for the treatment of postmenopausal women, with a later expansion to include adult men at high risk of fracture.[4]

What set strontium ranelate apart was its novel mechanism of action. It was promoted as the first in a new class of "dual action bone agents" (DABA).[5] This classification stemmed from its purported ability to simultaneously stimulate bone formation by osteoblasts and, to a lesser extent, inhibit bone resorption by osteoclasts.[4] This uncoupling of the normal bone remodeling cycle, which in osteoporosis is imbalanced in favor of resorption, theoretically leads to a net gain in bone mass and an improvement in bone strength.[4] This dual-action narrative was a powerful differentiator in a therapeutic landscape dominated by anti-resorptive agents like bisphosphonates, which primarily work by inhibiting osteoclast function.[9] The promise of a more physiological approach that could "rebalance" bone turnover was scientifically compelling and held significant clinical appeal.[8]