Wednesday, 18 Oct 2017

You are here

Romosuzumab Outperforms Teriparatide in Post-Bisphosphonate Osteoporosis

The STRUCTURE trial results have been reported in Lancet and have shown that after 12 months of therapy, romosozumab (ROMO) had superior gains in bone mineral density (BMD) compared to teriparatide (TER) in women with postmenopausal osteoporosis who have previously taken bisphosphonate therapy.

This phase 3 trial enrolled women (aged ≥55 to ≤90 years) with postmenopausal osteoporosis who had previously received oral bisphosphonate therapy for > 3 years and had a BMD T score of −2·5 or lower at the total hip, femoral neck, or lumbar spine; and a history of fracture. Patients were treated withe either ROMO (210 mg once monthly) or subcutaneous TER (20 μg once daily) and the primary endpoint was the percentage change in BMD at 12 months.

A total of 436 patients were randomized. At 12 months, the mean change in hip BMD was 2·6% (95% CI 2·2 to 3·0) for ROMO and −0·6% (−1·0 to −0·2) for TER treated patients (p<0·0001).

The frequency of adverse events and serious AEs were balanced between treatment groups. The most frequently reported adverse events were nasopharyngitis, hypercalcaemia and arthralgia. There were six (3%) patients in the romosozumab group compared with 12 (6%) in the teriparatide group with adverse events leading to drug withdrawal.

Thus for those requiring a bone-forming agent after bisphosphonates, it appears that the use of the anti-sclerostin drug, romosozumabm, may lead to better gains in hip BMD compared to teriparatide.

To date, more than 11,000 patients have received ROMO in clinical trials. Yet last month the FDA issued a complete response letter to the  manufacturers over concerns about cardiovascular events in subsequent trials. FDA has asked UCB and Amgen to provide additional data on the safety and efficacy of ROMO in their phase 3 active-comparator ARCH study and BRIDGE study.

The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Zilretta - a New Drug FDA Approved for Osteoarthritis of the Knee

Flexion Therapeutics announced friday that the U.S. Food and Drug Administration (FDA) has approved its osteoarthritis (OA) of the knee injectable steroid drug Zilretta with the indication of moderate-to-severe knee pain.

Zilretta is the commonly used triamcinolon acetonide combined with a drug delivery system designed to provide extended pain relief over three months.

UAB Researchers Shed Light on Age-Related Osteoporosis

Researchers from the University of Alabama at Birmingham (UAB) have detailed mechanisms leading to age-related bone loss and osteoporosis.

Osteoporotic Fractures as Back Pain in Older Men

The Journal of Bone and Mineral Research reports that older men with undiagnosed vertebral fractures are likely to report new or worsening back pain. (Citation source

Romosuzumab Followed by Alendronate is Best in Fracture Prevention

The NEJM reports that in high risk post-menopausal women, romosozumab for 12 months followed by alendronate resulted in a significantly lower fracture than alendronate alone. 

Bad Knees Through the Ages

The average American today is twice as likely to be diagnosed with knee osteoarthritis as in the years before World War II, Harvard scientists say. And the reasons are less clear than you might think.

Based on a study of more than 2,000 skeletons from cadaveric and archaeological collections across the United States, a Harvard report is the first to definitively show that knee osteoarthritis prevalence has dramatically increased in recent decades.