Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

Phase 4

Recruiting

• Conditions: Fragility Fracture; Femur; Fracture, Pertrochanteric; Clinical Trial
• Interventions: Drug: Strontium Ranelate; Drug: Lacto-N-Hexaose

• Registration Number: NCT05712616
• Lead Sponsor: Aga Khan University Hospital, Pakistan

Brief Summary

This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-10-28
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03
• Primary Completion: 2023-11-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients with age =/> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF.
• ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails.

Exclusion Criteria

• Patients with metabolic bone diseases.
• Patients with pathological fractures like tumor, osteopetrosis etc.
• Patients with prior Ischemic heart diseases and underwent PCI or CABG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strontium group	Strontium Ranelate	Trial drug given in the form of sachet 2gm/sachet once every day
Placebo (Lactose)	Lacto-N-Hexaose	Look, smell, taste alike lactose 2gm/sachet in form of sachet

Primary Outcome Measures

Name	Time	Method
change in Radiological healing on radiographs	12 weeks and 24 weeks	Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
change Bone mineral density through DEXA scan	pre-operatively or peri-admission and at 3 months	Difference in bone density T scores between pre-op and 3 months studies

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan