Trial · NCT04034199
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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 without normal distribution. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Serum albumin level as risk factor in osteoporosis and osteopenia in idiopathic inflammatory myopathies patients | at baseline | Serum albumin level |
| Secondary | Serum C reactive protein level as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients | at baseline | Serum C reactive protein level |
| Secondary | Erythrocyte sedimentation rate as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients | at baseline | Erythrocyte sedimentation rate |
| Secondary | Serum creatine kinase as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients | at baseline | Serum Creatine kinase level |
| Secondary | Disability as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patients | at baseline | Health assessment questionnaire disability index at baseline |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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