Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05712616

Acronym

STRONG

Enrollment

100

Registered

2023-02-03

Start date

2021-11-01

Completion date

2024-06-30

Last updated

2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial, Femur; Fracture, Pertrochanteric, Fragility Fracture

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.

Interventions

DRUGStrontium Ranelate

Dual mode of action, anabolic and anti-resorptive

DRUGLacto-N-Hexaose

Placebo look alike drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Pakistan

Contacts

Primary ContactDr. Marij Zahid, MSc. MBBS

marijzh@gmail.com+92-302-2302165

Backup ContactDr. Rizwan H Rashid, FCPS

rizwan.haroonrashid@aku.edu+92-2134864350

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026