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Clinical Trials/CTRI/2023/07/054697
CTRI/2023/07/054697
Recruiting
未知

A randomized controlled trial comparing the efficacy of denosumab, teriparatide or combination of denosumab and teriparatide on bone microarchitecture in patients being initiated on glucocorticoids

PGIMER0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere
Sponsor
PGIMER
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
PGIMER

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \> 18 years
  • •2\. Patients who are being started on glucocorticoids for various therapeutic indications.
  • •3\. Steroid dose \> 2\.5 mg Prednisone (or equivalent dose of other steroids) per day for at least three months.
  • •4\. Patients who are willing to give informed consent.

Exclusion Criteria

  • •1\. Baseline eGFR \< 45 ml/min/1\.73 m2
  • •2\. Patients who have received steroid dose of more than 2\.5 mg per day for more than 3 months in the past 1 year
  • •3\. Pregnant females.
  • •4\. Females with reproductive age group if they will plan for pregnancy for the next 2 years.
  • •5\. Patients with intrinsic bone disorders (FD or Skeletal dysplasia).
  • •6\. Patients on drugs affecting bone health or received anti\-osteoporotic therapy
  • •7\. Patients with secondary causes of osteoporosis (Endogenous Cushing Syndrome, Hyperprolactinemia, Primary hyperparathyroidism, CKD, Hypoparathyroidism etc.,)
  • •8\. Patients with structural abnormalities, kyphoscoliosis, hip replacement or surgical implants that may affect DXA study.
  • •9\. History of chronic diseases which can directly affect bone and mineral metabolism, like Rheumatoid arthritis, Ankylosing spondylitis, Marfan syndrome, EDS, Celiac disease, and Inflammatory bowel disease.
  • •10\. Patients who are not willing to give informed consent.

Outcomes

Primary Outcomes

Not specified

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