Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

NCT ID: NCT05712616

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fragility Fracture Femur; Fracture, Pertrochanteric Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Strontium group

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

Group Type ACTIVE_COMPARATOR

Strontium Ranelate

Intervention Type DRUG

Dual mode of action, anabolic and anti-resorptive

Placebo (Lactose)

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

Group Type PLACEBO_COMPARATOR

Lacto-N-Hexaose

Intervention Type DRUG

Placebo look alike drug

Interventions

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Strontium Ranelate

Dual mode of action, anabolic and anti-resorptive

Intervention Type DRUG

Lacto-N-Hexaose

Placebo look alike drug

Intervention Type DRUG

Other Intervention Names

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placebo Lactose

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Trauma Middle East and North Africa

UNKNOWN

Sponsor Role collaborator

Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Marij Zahid

Instructor orthopedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr. Marij Zahid, MSc. MBBS

Role: CONTACT

+92-302-2302165

Dr. Rizwan H Rashid, FCPS

Role: CONTACT

+92-2134864350

Facility Contacts

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Dr. Marij Zahid, MSc. MBBS

Role: primary

+92-302-2302165

Other Identifiers

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6189

Identifier Type: -

Identifier Source: org_study_id

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