Role of Strontium Ranelate in Proximal Femur Fragility Fractures. (STRONG)

February 1, 2023 updated by: Dr. Marij Zahid, Aga Khan University Hospital, Pakistan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Marij Zahid, MSc. MBBS
  • Phone Number: +92-302-2302165
  • Email: marijzh@gmail.com

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Aga Khan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Radiological healing on radiographs
Time Frame: 12 weeks and 24 weeks
Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks
12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change Bone mineral density through DEXA scan
Time Frame: pre-operatively or peri-admission and at 3 months
Difference in bone density T scores between pre-op and 3 months studies
pre-operatively or peri-admission and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University Hospital, Pakistan

Collaborators

AO Trauma Middle East and North Africa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2021

Primary Completion (ANTICIPATED)

November 30, 2023

Study Completion (ANTICIPATED)

June 30, 2024

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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