Summary of the article's key points
Study Question: The primary goal was to assess the changes in lumbar spine, femoral neck, and total hip BMD 24 months after the end of treatment with linzagolix.
Main Findings
The study found that the mean percentage changes in lumbar spine BMD from the post-treatment baseline to month 24 were small in most treatment groups and similar to the placebo group.
The most significant increase in BMD after stopping treatment was in the group that had the greatest BMD loss during the trial, which was the group that received add-back therapy (ABT).
The researchers concluded that the small changes in BMD observed do not appear to have any long-term, clinically relevant impact on the overall bone health of the treated individuals.
Study design
The PRIMROSE 3 study included participants who had completed at least 20 weeks of treatment in the prior PRIMROSE 1 or PRIMROSE 2 trials and had a DEXA scan within 35 days of their last treatment.
The study had a total of 130 subjects in the safety analysis set, with small group sizes ranging from 7 subjects in the placebo group to 30 in the highest dosage group.
The analysis focused on the 24-month visit, as earlier follow-up visits had a limited number of subjects, leading to high data variability.
Limitations
The article notes that a limitation of the study is the relatively small number of patients included.
Researchers concluded that these small BMD changes likely have no long-term clinical impact on bone health
