NCT04091243

Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users

Completed Phase 4 Last updated 4 September 2024

What this trial tests

Phase 4 trial testing Romosozumab in Glucocorticoid-induced Osteoporosis in 70 participants. Completed in 15 November 2023.

Timeline

15 January 2021

Primary endpoint
15 October 2023

15 November 2023

Quick facts

Lead sponsor	Tuen Mun Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	15 January 2021
Primary completion	15 October 2023
Estimated completion	15 November 2023
Sites	1 location across China

Drugs / interventions tested

• Romosozumab (romosozumab) — full drug profile →

Conditions studied

• Glucocorticoid-induced Osteoporosis — all drugs for Glucocorticoid-induced Osteoporosis →

Sponsor

Tuen Mun Hospital

Who can join

18 and older, any sex, with Glucocorticoid-induced Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Glucocorticoid (GC) is the main stay of treatment of many rheumatic diseases but is also an important cause of secondary osteoporosis. The long-term use of GCs increases the risk of fragility fracture at a much higher bone mineral density (BMD) than postmenopausal osteoporosis, indicating an additional deleterious effect of GC on bone quality. An increased relative risk of vertebral and hip fractures is demonstrated in chronic GC users, with fracture risk proportional to the daily dose of GC. Other studies have also confirmed that intermittent use of high-dose GC and the cumulative GC dose was associated with an augmented risk of osteoporotic fracture.

Romosozumab (ROMO) is a humanized monoclonal antibody against sclerostin. The landmark RCT has demonstrated efficacy of ROMO (210mg subcutaneously monthly) over placebo in reducing vertebral fractures by 73% at 12 months in 7180 postmenopausal women with osteoporosis of the hip at entry. Another RCT has demonstrated efficacy of ROMO in reducing vertebral and hip fractures in 4093 post-menopausal women at month 24.

There are no data regarding the efficacy of ROMO in GC-induced osteoporosis. Comparative study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet available in the literature. This prompts the current pilot study to compare the efficacy of ROMO with denosumab in high-risk patients receiving long-term GCs.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting strategies for bone diseases: signaling pathways and clinical studies.
   Xu H, Wang W, Liu X, Huang W, et al · · 2023 · cited 97× · PMID 37198232 · DOI 10.1038/s41392-023-01467-8
2. Bone-derived factors mediate crosstalk between skeletal and extra-skeletal organs.
   He T, Qin L, Chen S, Huo S, et al · · 2025 · cited 20× · PMID 40307216 · DOI 10.1038/s41413-025-00424-1