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Effect of dapagliflozin on bone health

Effect of add on dapagliflozin versus standard-of-care on bone and mineral indices in postmenopausal women with type2 diabetes mellitus: a randomized controlled study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041622
Enrollment
90
Registered
2022-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

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

Interventions

Intervention1: Dapagliflozin: Post menopausal with diabetes will be randomised into two groups. One group (intervention group) will receive dapagliflozin as an add on therapy in addition to standard c

Sponsors

Department of Endocrinology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Post-menopausal women ( duration of menopause > 5years ) and age 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 4.Duration of DM > 5 years

Exclusion criteria

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 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 Cushingââ?¬•s, Addisonââ?¬•s, acromegaly, prolactinoma, uncontrolled hypothyroidism, hyperthyroidism, celiac disease, primary hyperparathyroidism 12. Those unwilling for consent to participate and follow-up

Design outcomes

Primary

MeasureTime frame
Primary outcome : To assess changes in bone mineral density following treatment initiation with dapagliflozinTimepoint: Baseline, 3months, 6months, and one year—

Secondary

MeasureTime frame
1.To study the effect of dapagliflozin on bone turnover markers 2.To study the effect of dapagliflozin on mineral indices, PTH, 1,25(OH)2D2, FGF23 3.To study the effect of dapagliflozin on HRpQCT parameters 4.To study the effect of dapagliflozin on serum sclerostin 5.To study incident fractures (including verterbral) with dapagliflozin Timepoint: one year—

Countries

India

Contacts

Public ContactDr Mintu Mani Baruah

PGIMER, Chandigarh

jintu1862@gmail.com9906600116

Outcome results

None listed

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