A randomized controlled trial conducted to find out the efficacy of two anti-osteoporotic drugs denosumab and teriparatide either alone or together in combination to treat patients who are started on long term glucocorticoids.

Not Applicable

Conditions: Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere

Registration Number: CTRI/2023/07/054697

Lead Sponsor: PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the percent change in BMD at the lumbar spine and femoral neck at the end of intervention.Timepoint: •9 - 12 months

Secondary Outcome Measures

Name	Time	Method
1. To assess the dynamic changes in the BMD parameters <br/ ><br>2. To assess the dynamic changes in bone microarchitecture parameters using high resolution peripheral quantitative CT <br/ ><br>3. To assess the dynamic changes in bone turnover markers <br/ ><br>4. To assess the dynamic changes in the bone histomorphometry parameters <br/ ><br>5. To assess the incidence & predictors of fractures in study cohortTimepoint: 9-12 months