A study comparing denosumab injections given every 6 months versus every 9 months in postmenopausal women with osteoporosis

Randomised clinical trial evaluating the efficacy and safety of denosumab 6-monthly vs. 9-monthly in postmenopausal osteoporosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099664

Enrollment

100

Registered

2025-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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: Denosumab: 60 mg Denosumab administered subcutaneously every 9 monthly Control Intervention1: Denosumab: 60 mg Denosumab administered subcutaneously every 6 monthly

Eligibility

Inclusion criteria

Inclusion criteria: Postmenopausal women more than 50 years Duration of menopause more than 5 years eGFR more than 45 ml/min/1.73 m2 BMD T-score at lumbar spine or femoral neck less than and equal to -2.5 AND/OR Fragility fracture of the vertebrae (clinical or morphometric), hip, humerus, wrist

Exclusion criteria

Exclusion criteria: Secondary causes of osteoporosis (postmenopausal women with T2D will however not be excluded) Prior history of exposure to anti-osteoporotic therapies Recent history of dental extraction Prior history of use of glucocorticoids Present or past history of malignancy

Design outcomes

Primary

Measure	Time frame
Change in BMD at lumbar spine and femoral neck at 24 months (6 months after the last dose) in the two armsTimepoint: Change in BMD at lumbar spine and femoral neck at 24 months (6 months after the last dose) in the two arms	—

Secondary

Measure	Time frame
Co-primary objective: Frequency of incident fragility fractures at 24 months in the two armsTimepoint: 24 months;Change in HR-pQCT parameters at distal tibia and distal radius at 24 months in the two armsTimepoint: 24 months;Change in trabecular bone score (TBS) at 24 months in the two armsTimepoint: 24 months;Change in total PINP, beta-CTX and TRAP5b at 24 months and at 30 months in the 2 armsTimepoint: 24 months;Change in osteoclast cell lineages at 30 months (12 months after the last dose) in the 2 armsTimepoint: 30 months	—

Measure

Time frame

Co-primary objective: Frequency of incident fragility fractures at 24 months in the two armsTimepoint: 24 months;Change in HR-pQCT parameters at distal tibia and distal radius at 24 months in the two armsTimepoint: 24 months;Change in trabecular bone score (TBS) at 24 months in the two armsTimepoint: 24 months;Change in total PINP, beta-CTX and TRAP5b at 24 months and at 30 months in the 2 armsTimepoint: 24 months;Change in osteoclast cell lineages at 30 months (12 months after the last dose) in the 2 armsTimepoint: 30 months

—

Countries

India

Contacts

Public ContactRIMESH PAL

PGIMER Chandigarh

rimesh.ben@gmail.com8727053344

Outcome results

None listed

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