Choice of anti-osteoporotic therapy in postmenopausal women with type 2 diabetes mellitus at high risk of low trauma fractures.

Not Applicable

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2022/02/039978
• Lead Sponsor: Postgraduate Institute of Medical Education and Research Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the percent change in BMD at the lumbar spine and femoral neck at the end of intervention <br/ ><br>2. To assess the frequency of incident clinical major osteoporotic fractures (fragility) and/or morphometric vertebral fractures (fragility) during intervention <br/ ><br>Timepoint: 18 months

Secondary Outcome Measures

Name	Time	Method
1. To assess the percent change in BMD at the 33% radius at the end of intervention <br/ ><br>2. To assess the change in trabecular bone score (TBS) at the end of intervention <br/ ><br>3. To assess the change in high-resolution peripheral quantitative computed tomography (HR-pQCT) parameters at the end of intervention <br/ ><br>4. To assess the change in bone turnover markers (BTMs) during and at the end of intervention <br/ ><br>5. To assess the short-term change in glycemic control with anti-osteoporotic treatment as estimated using 2-weeks flash glucose monitoring <br/ ><br> <br/ ><br>Timepoint: 18 months