Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

NCT05712616 | Unknown Phase 4 DMC

• 1 other identifier: 6189
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fragility Fracture; Femur; Fracture, Pertrochanteric; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change Bone mineral density through DEXA scan

  pre-operatively or peri-admission and at 3 months

Study Arms (2)

Strontium group

ACTIVE COMPARATOR

Trial drug given in the form of sachet 2gm/sachet once every day

Drug: Strontium Ranelate

Placebo (Lactose)

PLACEBO COMPARATOR

Look, smell, taste alike lactose 2gm/sachet in form of sachet

Drug: Lacto-N-Hexaose

Interventions

Strontium Ranelate DRUG

Dual mode of action, anabolic and anti-resorptive

Also known as: placebo

Strontium group

Lacto-N-Hexaose DRUG

Placebo look alike drug

Also known as: Lactose

Placebo (Lactose)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead
• AO Trauma Middle East and North Africa: collaborator

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

strontium ranelate; lacto-N-hexaose; Lactose

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Central Study Contacts

Dr. Marij Zahid, MSc. MBBS

CONTACT

+92-302-2302165; marijzh@gmail.com

Dr. Rizwan H Rashid, FCPS

CONTACT

+92-2134864350; rizwan.haroonrashid@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor orthopedic surgery

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: February 3, 2023
• Study Start: November 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

PA (1)