Trial · NCT04034199
Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid
NCT04034199, Phase 3, Unknown, Kwong Wah Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid. Trials, record NCT04034199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04034199
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid
- NCT number
- NCT04034199
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Kwong Wah Hospital
- Conditions
- Idiopathic Inflammatory Myopathies, Osteoporosis, Osteopenia
- Interventions
- Denosumab, Zoledronic Acid
- First posted
- 2019-07-26
- Last updated
- 2019-07-26
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04034199
GET https://conductscience.org/api/trials/v1/NCT04034199/registered?page=2