Status:
UNKNOWN
Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid
Lead Sponsor:
Kwong Wah Hospital
Collaborating Sponsors:
Tung Wah Group of Hospitals
Conditions:
Idiopathic Inflammatory Myopathies
Osteoporosis, Osteopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Detailed Description
Background: With recent advances in diagnoses and classification of idiopathic inflammatory myopathies (IIM), an increasing number of newly diagnosed cases of IIM is expected. These patients are vuln...
Eligibility Criteria
Inclusion
- 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.
- Adult patients of at least 18 years of age and
- 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
- Pregnant patients
- Patients with juvenile onset of disease (\<18 years of age)
- Patients with pre-existing metabolic bone conditions
- Patients who are already on osteoporotic treatment other than calcium and vitamin D (including bisphosphonates, denosumab, teriparatide, raloxifene or strontium)
- Patients who are contraindicated to denosumab or zoledronic acid including severe renal impairment and hypersensitivity
- Patients who are not able to give informed consent
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04034199
Start Date
August 15 2019
End Date
March 31 2021
Last Update
July 26 2019
Active Locations (1)
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1
Kwong Wah Hospital
Hong Kong, Hong Kong, 00000