Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid
- Conditions
- Interventions
- Registration Number
- NCT04034199
- Lead Sponsor
- Kwong Wah Hospital
- 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 of glucocorticoid use for the treatment. Reduced bone mineral density is prevalent in local IIMs patients. Denosumab and zoledronic acid are established treatmen...
- Detailed Description
Background:
...
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Denosumab group Denosumab Patients randomized into the denosumab group will receive denosumab 60mg subcutaneously every 6 months, for a total duration of 1 year. DEXA scan would be repeated at 1 year. Zoledronic acid Zoledronic Acid Patients randomized into the denosumab group will receive one dose of zoledronic acid at 5mg intravenously. DEXA scan would be repeated at 1 year.
- Primary Outcome Measures
Name Time Method Change in bone mineral density at 12 months in denosumab and zoledronic acid group 12 months The primary outcome is change in bone mineral density at lumbar spine and hip measured by DEXA between the denosumab and zoledronic acid groups compared to control group at 12 months. Differences in BMD between two groups is compared with paired t-test.
- Secondary Outcome Measures
Name Time Method Drinking status as a risk factor for osteoporosis and osteopenia in IIMs patients at baseline Drinking status (Nondrinker, Social drinker, ex-drinker and current drinker) of the participantss would be recorded. Units of alcohol comsumption per week would be recorded.
Serum albumin level as risk factor in osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Serum albumin level
BMI as Risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Body weight and height will be combined to report Body Mass Index in kg/m\^2. Continuous variables are expressed as mean +/- standard deviation if they are normally distributed or as median and range otherwise. Independent Student's t-test is used for analyzing continuous variables with normal distribution and Mann-Whitney U test for continuous variables wit...
Prevalence of osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Prevalence of osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline. Osteoporosis is defined by a T score of \<-2.5 on DEXA scan and osteopenia is defined by T score between -1.0 and -2.5 by DEXA scan.
Smoking status as a risk factor for osteoporosis and osteopenia in IIMs patients at baseline Smoking status (Never smoker, ex-smoker and current smoker) of the participantss would be recorded. Chi-square test will be used to compare categorical variables.
Comparison of Change in Bone Mineral Density at lumbar spine and hip between the two treatment groups (denosumab and zoledronic acid) 12 months Comparison of Change in Bone mineral density at lumbar spine and hip between the two treatment groups (denosumab and zoledronic acid), as measured by Dual energy X-ray absorptiometry (DEXA scan). Differences in BMD between two groups is compared with paired t-test.
Menopausal status as a risk factor for osteoporosis and osteopenia in IIMs patients at baseline In female patients, menopausal status (pre-menopausal and menopausal) would be recoded
Age as Risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Age. Continuous variables are expressed as mean +/- standard deviation if they are normally distributed or as median and range otherwise. Independent Student's t-test is used for analyzing continuous variables with normal distribution and Mann-Whitney U test for continuous variables without normal distribution.
Different subtypes of IIMs and risks for osteoporosis and osteopenia at baseline Classification of IIMs according to Bohan and Peter criteria and presence of co-morbidities including chronic kidney disease, chronic liver disease, cardiovascular disease and diabetes mellitus. Personal history of previous vertebral or osteoporotic fracture and avascular necrosis. Chi-square test will be used to compare categorical variables.
Serum creatine kinase as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Serum Creatine kinase level
Adverse events associated with denosumab and zoledronic acid throughout study period (12 months) Occurence of adverse events and early termination of denosumab and zoledronic acid would be documented. The following events will be monitored and documented:
Mortality during treatment period Serious adverse events including infection requiring hopitalization, cardiac failure, stroke, myocardial infarction.
...Gender as a risk factor for osteoporosis and osteopenia in IIMs patients at baseline Gender of participants would be recorded. Chi-square test will be used to compare categorical variables.
Effect of medications on osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Drug history: Dosage of glucocorticoids (in milligram) at baseline and cumulative dose of glucocorticoids. Concomitant immunosuppressants and medication history.
Serum C reactive protein level as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Serum C reactive protein level
Erythrocyte sedimentation rate as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Erythrocyte sedimentation rate
Disability as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Health assessment questionnaire disability index at baseline
Effect of IIMS disease activity on osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline IIMs disease activity at baseline is measured by physician's and patient's global assessment by visual analogue scale
Effect of IIMs disease activity on osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline IIMs disease activity at baseline is measured by manual muscle testing 8
IIMs disease duration as Risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients at baseline Disease duration in years. Continuous variables are expressed as mean +/- standard deviation if they are normally distributed or as median and range otherwise. Independent Student's t-test is used for analyzing continuous variables with normal distribution and Mann-Whitney U test for continuous variables without normal distribution.
New fractures during study period during study period (12 months) New fractures including lumbar spine collapses during study period in two groups will be documented.
Trial Locations
- Locations (1)
Kwong Wah Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong