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Comparing Two Treatments (Romosozumab Followed by Denosumab vs Continuous Romosozumab) for Improving Bone Strength in Postmenopausal Women with Osteoporosis.

Evaluation of bone-mineral density and bone microarchitecture in postmenopausal osteoporosis patients receiving sequential therapy with Romosozumab followed by Denosumab versus continuous therapy of Romosozumab: A randomized controlled trial - BONSAI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108520
Enrollment
28
Registered
2026-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: M810- Age-related osteoporosis without current pathological fracture

Interventions

Intervention1: Romosozumab followed by Denosumab: Inj. Romosozumab (210 mg s.c) once a month for 6 months followed by Denosumab for next 6 month Control Intervention1: Continuous Romosozumab: Inj. Rom

Sponsors

Ashish Kakkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women aged 45 years or older 2. Duration of menopause more than 1 year 3. Diagnosed osteoporosis with T score less than or equal to minus 2.5 at lumbar spine or hip 4. High fracture risk with history of fragility fracture or FRAX 20 percent or more 5. Able to provide informed consent

Exclusion criteria

Exclusion criteria: Participants will be excluded if they meet any of the following criteria 1. Inability to provide written informed consent or comply with study procedures 2. Secondary causes of osteoporosis 3. Past history of cardiovascular stroke ASCVD or myocardial infarction 4. Evidence of untreated thyroid or parathyroid disorders abnormal serum calcium levels significant hepatic dysfunction with AST or ALT 3 times upper limit of normal or impaired renal function with creatinine clearance 45 mL per minute or less 5. Positive test for HIV hepatitis B surface antigen or hepatitis C virus 6. Malignancy within the past 5 years except adequately treated non melanoma skin cancer or carcinoma in situ of cervix or breast 7. Known hypersensitivity to mammalian cell derived products or intolerance to calcium supplements

Design outcomes

Primary

MeasureTime frame
Percentage change in lumbar spine (L1-L4) BMDTimepoint: Baseline to 12 months.—

Secondary

MeasureTime frame
Change in Bone Mineral Density (BMD) at the hip and femoral neck from baseline to 12 months.Timepoint: 12 months;Changes in high-resolution peripheral quantitative computed tomography (HR-pQCT) parameters at the distal tibia and distal radius (Exploratory)Timepoint: 6 months and 12 months.;Incidence of Fragility FracturesTimepoint: 12 months;Pharmacoeconomic OutcomeTimepoint: 12 months;Safety (Adverse Events)Timepoint: Over 12 months—

Countries

India

Contacts

Public ContactDr Ashish Kakkar

Postgraduate Institute of Medical Education and Research

drashishkakkar@gmail.com01722755297

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026