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

Primary Purpose

Fragility Fracture, Femur; Fracture, Pertrochanteric, Clinical Trial

Status

Recruiting

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

Strontium Ranelate

Lacto-N-Hexaose

About this trial

This is an interventional treatment trial for Fragility Fracture

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Strontium group

Placebo (Lactose)

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in Radiological healing on radiographs

Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks

Secondary Outcome Measures

change Bone mineral density through DEXA scan

Difference in bone density T scores between pre-op and 3 months studies

Full Information

NCT ID

NCT05712616

First Posted

October 28, 2022

Last Updated

February 1, 2023

Sponsor

Aga Khan University Hospital, Pakistan

Collaborators

AO Trauma Middle East and North Africa

1. Study Identification

Unique Protocol Identification Number

NCT05712616

Brief Title

Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

Acronym

STRONG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aga Khan University Hospital, Pakistan

Collaborators

AO Trauma Middle East and North Africa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fragility Fracture, Femur; Fracture, Pertrochanteric, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Strontium group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo (Lactose)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Strontium Ranelate

Other Intervention Name(s)

placebo

Intervention Description

Dual mode of action, anabolic and anti-resorptive

Intervention Type

Drug

Intervention Name(s)

Lacto-N-Hexaose

Other Intervention Name(s)

Lactose

Intervention Description

Placebo look alike drug

Primary Outcome Measure Information:

Title

change in Radiological healing on radiographs

Description

Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks

Time Frame

12 weeks and 24 weeks

Secondary Outcome Measure Information:

Title

change Bone mineral density through DEXA scan

Description

Difference in bone density T scores between pre-op and 3 months studies

Time Frame

pre-operatively or peri-admission and at 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr. Marij Zahid, MSc. MBBS

Phone

+92-302-2302165

marijzh@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dr. Rizwan H Rashid, FCPS

Phone

+92-2134864350

rizwan.haroonrashid@aku.edu

Facility Information:

Facility Name

Aga Khan University Hospital

City

Karachi

State/Province

Sindh

ZIP/Postal Code

74800

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Marij Zahid, MSc. MBBS

Phone

+92-302-2302165

marijzh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

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