2022ACR: romozosumab VS denosumab, how to choose for patients with glucocorticoid-induced osteoporosis?

Glucocorticoid osteoporosis (GIOP) is the most common clinical secondary osteoporosis, which can cause vertebral body, rib and hip fractures in severe cases, seriously affecting the quality of life of
patients.
GIOP focuses on prevention and early treatment, but it has not received much attention at present, and prevention and treatment are often not active
.

At the 2022 ACR Annual Meeting on Rheumatism, a study compared romozosumab (ROMO) with denosumab ( DEN) efficacy and safety in patients at high risk of GIOP, both drugs were found to be well tolerated, and ROMO may become GIOP New options
for high-risk patients.

The researchers recruited 70 adult patients who received a daily dose of ≥ 5 mg/day for 1≥2 months who were at moderate/high risk of osteoporotic fractures, including a history of fragility fractures , a DEXA T score of ≤-2.
5 or a Z-score of -3.
0 ≤ or as estimated by FRAX High risk
of major fractures at 10 years.
Meanwhile, participants were given calcium/vitamin D daily and randomized to receive ROMO (210mg SC per month) or DEN (60 mg SC every 6 months) for 12 months.

Subsequently, both groups received another DEN (60 mg every 6 months) in cycles of 12.

The primary endpoint of the study was change in bone mineral density (BMD) in the lumbar spine from baseline to 12 months.

Secondary endpoints included changes in BMD in the non-dominant hip and femoral neck at 12 months, changes in markers of bone turnover, new vertebral fractures, changes in BMD in the hip and spine at 24 months, and adverse events
。

The results showed that 63 (90%) participants ended up completing the study, aged 62.
6±9.
1 years, and 96% were women
.
At enrollment, the average prednisolone dose per day was 6.
6±3.
5 mg
.
Thirty-four (48.
6%) and 35 (50%) patients had spine/hip joints /History of osteoporosis and fragility fractures of the femoral neck
.
Thirty-three (47%) patients were taking oral bisphosphonates
before taking ROMO and DEN drugs for the first time.

Although baseline demographics and osteoporosis risk factors did not differ significantly between groups, patients treated with ROMO had a ratio of hip/femoral neck BMD to serum vitamin D3 levels Patients treated with DEN are low
.
At month 12, there was a significant increase
in spinal BMD in both the ROMO and DEN groups.

Spinal BMD at month 12 after adjusting for baseline BMD values, age, sex, osteoporosis risk factors, and cumulative prednisolone dose over 12 months The between-group differences were statistically significant (P<0.
001).

The corresponding increase in hip BMD was +1.
6% ±3.
3% (p=0.
01) in the ROMO group and in the DEN group +1.
6%±2.
6%（p=0.
003）
。 No significant between-group differences
were observed in hip BMD.

From baseline to 12 months, the increase in femoral neck BMD was not significant
in either group.
In patients treated with DEN, serum CTX (-34.
7± 54.
8%; P=0.
002) and P1NP (-35.
1±43.
3%; P<0.
001) both decreased
significantly.
However, in the ROMO group, CTX (-18.
1± 76.
9% was observed; p=0.
18) did not decrease significantly, but P1NP (+1.
7±70.
3%; p=0.
89).

After 12 months, only one new vertebral fracture occurred
in the ROMO group.

In terms of the most common adverse events, self-limited injection site pain/redness occurred in both groups, although it was significantly more common
in patients treated with ROMO.
Musculoskeletal pain developed in the ROMO group and the DEN group with 2 and 3 patients
, respectively.
Two patients treated with DEN developed mild hypocalcaemia and hypercalcaemia
.

Taken together, these results suggest that ROMO may provide new treatment options
for patients with high-risk GIOP.

Resources

https://acrabstracts.
org/abstract/romosozumab-versus-denosumab-in-high-risk-patients-with-glucocorticoid-induced-osteoporosis-a-pilot-randomized-controlled-trial/