Effect of dapagliflozin on bone health

Phase 3

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

Registration Number: CTRI/2022/04/041622

Lead Sponsor: Department of Endocrinology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Post-menopausal women ( duration of menopause > 5years ) and age < 65 years diagnosed with T2DM and being initiated on SGLT2i shall be enrolled into the study.

2.Patients on diet alone therapy or with other anti-diabetic agents (metformin, alpha-glucosidase inhibitors, DPP4i or insulin) may be used for achieving glycaemic targets.

3. HbA1C <10 %

4.Duration of DM > 5 years

Exclusion Criteria

1. Current users of any of the SGLT2i (Cana or Dapa or Empa )

2.Patients on bone active agents (anti-resrorptives or osteoanabolics)

3.Patients on chronic glucocorticoid therapy ( >3 months)

4.Other drugs (thiazolidinediones, phenytoin, tamoxifen, estrogen, combined OCs)

5.eGFR <30ml/min/m2

6.Contraindication or hypersensitivity to SGLT2i

7.Patients with T1DM, FCPD or known case of secondary diabetes

8.Pregnant or lactating women

9.Premature ovarian insufficiency

10.HbA1C >10%

11.Known case and/or specific features of CushingÃ¢â?¬•s, AddisonÃ¢â?¬•s, acromegaly, prolactinoma, uncontrolled hypothyroidism, hyperthyroidism, celiac disease, primary hyperparathyroidism

12.Those unwilling for consent to participate and follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome : To assess changes in bone mineral density following treatment initiation with dapagliflozinTimepoint: Baseline, 3months, 6months, and one year

Secondary Outcome Measures

Name	Time	Method
1.To study the effect of dapagliflozin on bone turnover markers <br/ ><br>2.To study the effect of dapagliflozin on mineral indices, PTH, 1,25(OH)2D2, FGF23 <br/ ><br>3.To study the effect of dapagliflozin on HRpQCT parameters <br/ ><br>4.To study the effect of dapagliflozin on serum sclerostin <br/ ><br>5.To study incident fractures (including verterbral) with dapagliflozin <br/ ><br>Timepoint: one year