Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

Clinical Trial Clinical Trial

— STRONG  

Official title:

Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712616
• Other study ID #: 6189
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Aga Khan University Hospital, Pakistan
• Contact: Dr. Marij Zahid, MSc. MBBS
• Phone: +92-302-2302165
• Email: marijzh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Trial
• Fractures, Bone
• Fragility Fracture

Intervention

Drug:
• Strontium Ranelate
Dual mode of action, anabolic and anti-resorptive
• Lacto-N-Hexaose
Placebo look alike drug

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University Hospital, Pakistan	AO Trauma Middle East and North Africa

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Radiological healing on radiographs	Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks	12 weeks and 24 weeks
Secondary	change Bone mineral density through DEXA scan	Difference in bone density T scores between pre-op and 3 months studies	pre-operatively or peri-admission and at 3 months