Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users

NCT04091243 | Completed Phase 4

• 1 other identifier: NTWC/REC/19074
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucocorticoid-induced Osteoporosis

Keywords

glucocorticoid; osteoporosis; rheumatic diseases

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (BMD)

  Changes in BMD at lumbar spine from baseline

  month 12

Secondary Outcomes (2)

• Bone mineral density (BMD)

  month 12

• bone turnover markers

  months 6,12,18 and 24

Study Arms (2)

Romosozumab

EXPERIMENTAL

Romosozumab (210mg) subcutaneously every month for 12 doses

Drug: Romosozumab

Denosumab

ACTIVE COMPARATOR

Denosumab subcutaneously (60mg) every 6 months for 2 doses

Drug: Romosozumab

Interventions

Romosozumab DRUG

Experimental drug for the treatment of glucocorticoid induced osteoporosis

Denosumab; Romosozumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (women or men) \>18 years of age
• Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥5mg/day for ≥12 months.
• High risk of osteoporotic fracture (in subjects \<40 years, personal history of fragility/vertebral fracture, bone mineral density \[BMD\] of the hip/spine Z score ≤ -3.0, loss of BMD \>10% per year or new fracture; in subjects aged ≥40 years, personal history of fragility/vertebral fracture, BMD of the hip/spine T score ≤ -2.5, GC-adjusted 10-year major osteoporotic fracture risk ≥20% or hip fracture risk ≥3% by FRAX \[ie. multiplying risk by 1.15 for the former and 1.20 for the latter when prednisolone ≥7.5mg/day\], or new fracture development).
• \. Informed consent from patients. 6. Willing to comply with all study procedures

You may not qualify if:

• Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents within 24 months of study entry.
• Premenopausal women who plan for pregnancy within 24 months of study entry.
• Patients with a known past history of atherosclerotic cardiovascular or cerebrovascular disease.
• Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
• Patients with unexplained hypocalcemia.
• Patients with serum creatinine level of \>=200umol/L.

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Osteoporosis; Rheumatic Diseases

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chi Chiu Mok, MD, FRCP

  Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: An open randomized parallel group controlled trial

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: January 15, 2021
• Primary Completion: October 15, 2023
• Study Completion: November 15, 2023
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)