Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid

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
Inclusion Criteria
  1. Adult patients of at least 18 years of age and
  2. 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.
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Exclusion Criteria
  1. Pregnant patients
  2. Patients with juvenile onset of disease (<18 years of age)
  3. Patients with pre-existing metabolic bone conditions
  4. Patients who are already on osteoporotic treatment other than calcium and vitamin D (including bisphosphonates, denosumab, teriparatide, raloxifene or strontium)
  5. Patients who are contraindicated to denosumab or zoledronic acid including severe renal impairment and hypersensitivity
  6. Patients who are not able to give informed consent
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Denosumab groupDenosumabPatients 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 acidZoledronic AcidPatients 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
NameTimeMethod
Change in bone mineral density at 12 months in denosumab and zoledronic acid group12 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
NameTimeMethod
Drinking status as a risk factor for osteoporosis and osteopenia in IIMs patientsat 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 patientsat baseline

Serum albumin level

BMI as Risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patientsat 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 patientsat 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 patientsat 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 patientsat 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 patientsat 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 osteopeniaat 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 patientsat baseline

Serum Creatine kinase level

Adverse events associated with denosumab and zoledronic acidthroughout 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 patientsat 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 patientsat 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 patientsat baseline

Serum C reactive protein level

Erythrocyte sedimentation rate as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patientsat baseline

Erythrocyte sedimentation rate

Disability as risk factor for osteoporosis and osteopenia in idiopathic inflammatory myopathies patientsat baseline

Health assessment questionnaire disability index at baseline

Effect of IIMS disease activity on osteoporosis and osteopenia in idiopathic inflammatory myopathies patientsat 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 patientsat 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 patientsat 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 periodduring 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

🇭🇰

Hong Kong, Hong Kong

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