Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid

• Status: Unknown status
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Idiopathic inflammatory myopathies (IIM) patients are at high risk of development of reduced bone mineral density due to impairment of functional status due to the disease and a relatively high dose of glucocorticoid use for the treatment. Reduced bone mineral density is prevalent in local IIMs patients. Denosumab and zoledronic acid are established treatments for osteoporosis in postmenopausal women and glucocorticoid-induced osteoporosis. However, the role of these treatments in reduced bone mineral density including osteoporosis and osteopenia related to IIMs are lacking. There is also no evidence on comparing the efficacy of the two agents. Therefore, the investigators conducted this prospective randomized controlled study to compare the efficacies of denosumab and zoledronic acid in treating reduced bone mineral density in IIMs patients. The hypothesis in this study is that treatment by denosumab or zoledronic acid would improve bone mineral density in IIMs patients with reduced bone mineral density.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kwong Wah Hospital
• Collaborator: Tung Wah Group of Hospitals
• Treatments: Denosumab; Zoledronic Acid

Criteria

All idiopathic inflammatory myopathies (IIMs) patients under follow-up in Kwong Wah Hospital are invited to participate in this study.

IIMs are diagnosed by rheumatologist according to Bohan and Peter Criteria. Eligible patients will have dual-energy X-ray absorptiometry (DEXA) scan performed at baseline.

Inclusion Criteria:

1. Adult patients of at least 18 years of age and

2. Evidence of reduced BMD in osteopenia (defined by T-score of -0.1 to -2.5) or osteoporosis range (defined by T-score of < -2.5) at baseline by dual-energy X-ray absorptiometry (DEXA) scan.

Exclusion Criteria:

1. Pregnant patients

2. Patients with juvenile onset of disease (<18 years of age)

3. Patients with pre-existing metabolic bone conditions

4. Patients who are already on osteoporotic treatment other than calcium and vitamin D (including bisphosphonates, denosumab, teriparatide, raloxifene or strontium)

5. Patients who are contraindicated to denosumab or zoledronic acid including severe renal impairment and hypersensitivity

6. Patients who are not able to give informed consent