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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.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054697
Enrollment
60
Registered
2023-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Patients on long term glucocorticoids will receive intervention with anti-osteoporotic drug along with standard doses of calcium and vitamin D: Group A - Inj. Denosumab 60 mg subcutaneo

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: 1. Baseline eGFR 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. To assess the dynamic changes in the BMD parameters 2. To assess the dynamic changes in bone microarchitecture parameters using high resolution peripheral quantitative CT 3. To assess the dynamic changes in bone turnover markers 4. To assess the dynamic changes in the bone histomorphometry parameters 5. To assess the incidence & predictors of fractures in study cohortTimepoint: 9-12 months—

Countries

India

Contacts

Public ContactDr Durairaj Arjunan

PGIMER

duraipgi@gmail.com09626680378

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026