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NCT04034199
Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid
Phase 3 trial testing Denosumab in Idiopathic Inflammatory Myopathies in 40 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Kwong Wah Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 15 August 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Denosumab (DENOSUMAB) — full drug profile →
- Zoledronic Acid (ZOLEDRONIC ACID) — full drug profile →
Conditions studied
- Idiopathic Inflammatory Myopathies — all drugs for Idiopathic Inflammatory Myopathies →
- Osteoporosis, Osteopenia — all drugs for Osteoporosis, Osteopenia →
Sponsor
Kwong Wah Hospital
Who can join
18 and older, any sex, with Idiopathic Inflammatory Myopathies or Osteoporosis, Osteopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04034199
- Europe PMC full search
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Other recruiting trials for Idiopathic Inflammatory Myopathies
Currently open trials in the same condition.
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Other Kwong Wah Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04034199 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kwong Wah Hospital
- Last refreshed: 26 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04034199.
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