Friday, 22 Jun 2018

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

Update on Osteoporosis

This session was an update on the management of osteoporosis given by Professor Christian Roux from France.

He emphasised the use of composite risk score like the FRAX. He highlighted that the risk of vertebral fracture is increased by both the recency and severity of previous vertebral fracture. So it is important that those with vertebral fractures are followed up and treated appropriately to prevent subsequent fractures.

Restless Sleep and Inactivity Intertwined in OA

Adults with osteoarthritis (OA) of the knee who frequently experienced restless sleep were less likely to engage in potentially beneficial moderate-to-vigorous physical activity, analysis of data from the Osteoarthritis Initiative found.

FDA Approves Denosumab for Glucocorticoid-Induced Osteoporosis

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Bisphosphonate Drug Holidays May Result in Fractures

A report in Endocrine Practice shows that drug holidays from bisphosphonates results in a 15% risk of fractures.  (Citation source:

USPSTF Recommendations on Vitamin D, Calcium Supplementation to Prevent Fractures

The U.S. Preventive Services Task Force (USPSTF) concludes current scientific evidence is insufficient regarding the use of vitamin D and calcium, alone or in combination, to prevent fractures in men and premenopausal women. The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium to prevent fractures in postmenopausal women. Current scientific evidence is insufficient regarding the use of vitamin D and calcium at doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium in postmenopausal women.