Clincosm LogoSign in Get a demo

STRONG: Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

Sponsor
Aga Khan University Hospital, Pakistan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05712616
Collaborator
AO Trauma Middle East and North Africa (Other)
100
Enrollment
1
Location
2
Arms
31.9
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Strontium group

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

Drug: Strontium Ranelate
Dual mode of action, anabolic and anti-resorptive
Other Names:
  • placebo

    		•
    Placebo Comparator: Placebo (Lactose)

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

    Drug: Lacto-N-Hexaose
    Placebo look alike drug
    Other Names:
  • Lactose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aga Khan University Hospital Karachi Sindh Pakistan 74800

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Marij Zahid, Instructor orthopedic surgery, Aga Khan University Hospital, Pakistan
    ClinicalTrials.gov Identifier:
    NCT05712616
    Other Study ID Numbers:
    • 6189
    First Posted:
    Feb 3, 2023
    Last Update Posted:
    Feb 3, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone
    Strontium ranelate

    Study Results

    No Results Posted as of Feb 3, 2023