Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Teriparatide plus routine standard of care (Group A): Injection Teriparatide 20 micrograms per day is to be administered subcutaneously along with routine standard of care (calcium and
Sponsors
Postgraduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory type 2 diabetes mellitus postmenopausal females 2. Age more than or equal to 50 years 3. Postmenopausal status for at least 5 years 4. Duration of type 2 diabetes mellitus at least 5 years 5. Baseline eGFR more than or equal to 45 ml/min/1.73 m2 6. Baseline HbA1c 7-10% 7. Baseline BMI more than or equal to 23 kg/m2 8. Prior vertebral (clinical or morphometric), hip, radius, humerus fragility fracture OR 9. Baseline BMD T-score at lumbar spine or femoral neck less than or equal to -2.5 (corrected for T2D) and baseline FRAX score (corrected for T2D) indicating a 10-year probability of hip fracture more than or equal to 2.5% or of major osteoporotic fracture more than or equal to 9%. 10. Those willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus or latent autoimmune diabetes in adults, or secondary diabetes mellitus 2. Prior history of use of bone-active therapies (bisphosphonates, teriparatide, denosumab, selective estrogen receptor modulators, hormone replacement therapies, calcitonin) 3. Prior history of glucocorticoid use at a dose more than or equal to 15 mg (prednisolone or equivalent) for more than or equal to 3 months. 4. History of use of pioglitazone, thiazides, or canagliflozin over last 6 months 5. Hyperthyroidism (overt/subclinical) or overt hypothyroidism (detected during baseline screening) 6. History of hypoparathyroidism or primary hyperparathyroidism 7. History of acromegaly 8. History of Addison disease or Cushingââ?¬•s syndrome 9. History of gonadal insufficiency (primary or secondary) 10. History of hypercalcemia (or detected during baseline screening) 11. Elevated hepatic transaminase levels more than or equal to 3 times upper limit of normal (detected during baseline screening) 12. Any solid organ or bone marrow transplant 13. History of any active or past malignancy 14. History of gastrointestinal disorders and malabsorption states, namely, celiac disease (also screened at baseline), inflammatory bowel disease, chronic hepatitis, bowel resection, chronic liver disease, gastrectomy, lactose intolerance 15. History of bone marrow related disorders, namely, leukemia, lymphoma, hemochromatosis, multiple myeloma (also screened at baseline), sarcoidosis, sickle cell anemia, thalassemia, amyloidosis 16. History of rheumatological disorders, namely, rheumatoid arthritis, ankylosing spondylitis, Marfans syndrome, Ehler-Danlos syndrome 17. History of any condition that may affect bone metabolism, namely, Pagetââ?¬•s disease, osteopetrosis, osteogenesis imperfecta, hypophosphatasia 18. History of recent tooth extraction (within 6 months of screening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the percent change in BMD at the lumbar spine and femoral neck at the end of intervention 2. To assess the frequency of incident clinical major osteoporotic fractures (fragility) and/or morphometric vertebral fractures (fragility) during intervention Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the percent change in BMD at the 33% radius at the end of intervention 2. To assess the change in trabecular bone score (TBS) at the end of intervention 3. To assess the change in high-resolution peripheral quantitative computed tomography (HR-pQCT) parameters at the end of intervention 4. To assess the change in bone turnover markers (BTMs) during and at the end of intervention 5. To assess the short-term change in glycemic control with anti-osteoporotic treatment as estimated using 2-weeks flash glucose monitoring Timepoint: 18 months | — |
Countries
India
Contacts
Public ContactDr Trupti Nagendra Prasad
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed